- Current Regulatory Status of Over-the-Counter Products | 11 | v2

ABSTRACT

Sedative Nighttime sleep aid Sleep aid IIE IIE [54 FR 6826] Sedative Daytime sedative Sedative IISE IISE 310.519(a) = == = = == = = == = = == = = == = = == = Acetanilide Internal analgesic Internal analgesic Analgesic IIS IIS Pending Internal analgesic Internal analgesic Antipyretic IIS IIS Pending Internal analgesic Internal analgesic Antirheumatic IISE not OTC n/a Acetic acid = == = Otic Swimmer’s ear

prevention n/a IIIE 310.545(15)(i)

Contraceptive/vaginal Vaginal Alters vaginal pH IIIE Withdraw n/a Miscellaneous external Wart remover Wart remover IIISE IIISE [55 FR 33254] Acetic acid, glacial Miscellaneous external Wart remover Wart remover IIIE IIISE [55 FR 33254] Miscellaneous external Corn/callus remover Corn/callus remover IIIE IIISE [55 FR 33261] Acetone Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Skin protectant Astringent IISE IISE 310.545(18)(ii) Acidulated phosphate fluoride

(sod fluoride/sod phos/phos acid) Dental Anticaries Anticavity dental rinse I I 355.10(a)(2)(ii) Acidulated phosphate fluoride

(sodium fluoride/hydrogen fluoride) Dental Anticaries Anticavity dental rinse IIS IIS 355.10(a)(2)(ii) Acidulated phosphate fluoride (sodium

fluoride/sodium phos dibasic/phos acid) Dental Anticaries Anticavity dental rinse I I 355.10(a)(3)(ii) Agar Laxative Laxative Bulk laxative IIIE IIIE 310.545(12)(i) Alanine Miscellaneous internal Benign prostatic

hypertrophy Benign prostatic

hypertrophy IIE IIISE 310.532(a)

Alcloxa Antimicrobial II Acne Acne IIE IIE 310.545(1) Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(22)(ii) Hemorrhoidal Anorectal Keratolytic (external) I I 346.20(a) Hemorrhoidal Anorectal Keratolytic

(intrarectal) I I 346.20(a)

Review Panel Report Drug Category ANPR PR FR

Alcohol Miscellaneous external Alcohols (topical) Antiseptic I Defer n/a Miscellaneous external Mercury First aid antiseptic n/a I Pending Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external External analgesic Fever blister (topical) Defer Defer n/a Miscellaneous external External analgesic Insect bite/sting IISE IISE 310.545(a)(10)(vi) Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IISE 310.545(a)(10)(vii)

Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(18)(v) Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer IISE 310.545(a)(18)(vi)

Miscellaneous external Skin protectant Fever blister (topical) IISE IISE Pending Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Miscellaneous internal Menstrual/diuretic Analgesic adjuvant n/a IISE 310.545(a)(24)(i) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Oral cavity Oral health care Antimicrobial IIIE IIISE Pending Alcohol, 14% [see Alcohol] ==== ==== ==== ==== ==== ==== Alcohol, ethoxylated alkyl ==== Insect bite/sting Insect bite/sting n/a n/a 310.545(a)(18)(v)(A) Aldioxa Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(ii) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer IIISE Pending Alfalfa Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Alfalfa leaves Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Alginic acid Antacid Antacid Antacid IIIE IIIE [39 FR 19873] Miscellaneous internal Weight control Anorectic IIIE IISE 310.545(a)(20) Alkaloids of sabadilla [see sabadilla alkaloids] ==== ==== ==== ==== ==== ==== Alkyl arylsulfonate Contraceptive/vaginal Vaginal Lowers surface

tension mucolytic effects

IIIE Withdraw n/a

Alkyl dimethyl amine oxide and alkyl dimethyl glycine

==== Gingivitis/plaque Antiplaque/gingivitis n/a IIISE Pending Alkyl isoquinolinium bromide Antimicrobial II Acne Acne IISE IISE 310.545(a)(1) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff IISE IIIE 310.545(a)(7)

Alkyldimethyl benzylammonium chloride [see benzalkonium chloride]

==== ==== ==== ==== ==== ==== Allantoin Contraceptive/vaginal Vaginal Minor irritations IIIE Withdraw n/a Dental Oral mucosal injury Wound healing agent IIIE IIIE 310.534(a) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis/ psoriasis

IIIE IIIE 310.545(a)(7)

Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external External analgesic Fever blister (topical) Defer n/a Pending Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IISE Pending

Miscellaneous external Hair growth/loss Hair grower IISE n/a 310.527(a) Miscellaneous external Skin protectant Diaper rash Defer I Pending Miscellaneous external Skin protectant Fever blister (topical) Defer I Pending Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer IISE Pending

Review Panel Report Drug Category ANPR PR FR

Miscellaneous external Corn/callus remover Corn/callus remover IISE IISE [55 FR 33261] Topical analgesic Skin protectant Skin protectant I I 347.10(a) Topical analgesic Skin protectant Wound healing agent IIIE IIIE 310.545(a)(18)(i)(A) Allantoin (with aminobenzoic acid) Topical analgesic Sunscreen Sunscreen IIIE IIIE [64 FR 27682] Allyl isothiocyanate Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(topical/inhalant) IISE IISE 310.545(a)(6)(ii)(A)

Miscellaneous external External analgesic Fever blister (topical) Defer IISE 310.545(a)(10)(v) Topical analgesic External analgesic Counterirritant I I Pending Almadrate sulfate Miscellaneous internal Digestive aid Digestive aid (ippuad) IIIE n/a 310.545(a)(8)(ii) Aloe ==== Skin protectant Diaper rash n/a Withdraw n/a Contraceptive/vaginal Vaginal Minor irritations IIIE Withdraw n/a Laxative Laxative Stimulant laxative I I/IIIS 310.545(a)(12)(iv)(C) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Aloe extract ==== Laxative Stimulant laxative n/a n/a 310.545(a)(12)(iv)(C) Aloe flower extract ==== Laxative Stimulant laxative n/a n/a 310.545(a)(12)(iv)(C) Aloe vera [see aloe] ==== Gingivitis/plaque Antiplaque/gingivitis n/a IIIE Pending Aloe vera stabilized [see aloe] ==== ==== ==== ==== ==== ==== Aloes [see aloe] ==== ==== ==== ==== ==== ==== Aloin Laxative Laxative Stimulant laxative IIISE IIISE 310.545(a)(12)(iv)(A) Alum (powdered alum) [see alum,

ammonium/alum, potassium] ==== ==== ==== ==== ==== ==== Alum [see alum, ammonium/alum, potassium] ==== ==== ==== ==== ==== ==== Alum ammonium [see alum, ammonium] ==== ==== ==== ==== ==== ==== Alum, ammonium Contraceptive/vaginal Vaginal Astringent IIIE Withdraw n/a Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Oral cavity Astringent Astringent I Defer n/a Oral cavity Oral health care Astringent I I Pending Alum, potassium Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(a)(22)(ii) Antiperspirant Antiperspirant Antiperspirant IIISE IIISE 310.545(a)(4) Contraceptive/vaginal Vaginal Astringent IIIE Withdraw n/a Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Skin protectant Astringent IISE IISE 310.545(18)(ii) Oral cavity Oral health care Astringent I I Pending Aluminum acetate Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Astringent I I 347.12(a) Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Astringent I I 347.10(a) Miscellaneous external Skin protectant Diaper rash Defer IIISE Pending Aluminum aspirin [see aspirin, aluminum] ==== ==== ==== ==== ==== ==== Aluminum bromohydrate Antiperspirant Antiperspirant Antiperspirant IISE IISE 310.545(a)(4) Aluminum carbonate (gel)

[see aluminum hydroxide] ==== ==== ==== ==== ==== ==== Aluminum carbonate gel (basic) Antacid Antacid Antacid I I 331.11(a)(1) Aluminum carbonate gel

[see basic aluminum carbonate gel] ==== ==== ==== ==== ==== ====

Review Panel Report Drug Category ANPR PR FR

Aluminum chlorhydroxy complex Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Aluminum chloride (aerosol) (15% or less

aqueous solution) Antiperspirant Antiperspirant Antiperspirant IIIS IIIS 310.545(a)(4) Aluminum chloride (alcoholic solutions) Antiperspirant Antiperspirant Antiperspirant IIS IIS 310.545(a) (4) Aluminum chloride (nonaerosol) (15% or less

aqueous solution) Antiperspirant Antiperspirant Antiperspirant I I 350.10(a) Aluminum chloride hexahydrate Miscellaneous external External analgesic Astringent n/a IIIE Pending Aluminum chlorohydrate (aerosol) Antiperspirant Antiperspirant Antiperspirant IIIS I 350.10(b) Aluminum chlorohydrate (nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(b) Aluminum chlorohydrex Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Aluminum chlorohydrex polyethylene glycol

(aerosol) Antiperspirant t Antiperspiran Antiperspirant IIIS I 350.10(c) Aluminum chlorohydrex polyethylene glycol

(nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(c) Aluminum chlorohydrex polyethylene glycol

complex [see name with “complex”] ==== ==== ==== ==== ==== ==== Aluminum chlorohydrex polyplene glycol

(aerosol) Antiperspirant Antiperspirant Antiperspirant IIIS I 350.10(d) Aluminum chlorohydrex polyplene glycol

(nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(d) Aluminum dichlorohydrate Antiperspirant Antiperspirant Antiperspirant IIIS I 350.10(e) Aluminum dichlorohydrate (nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(e) Aluminum dichlorohydrex polyethylene glycol

(aerosol) Antiperspirant Antiperspirant Antiperspirant IIIS I 350.10(f) Aluminum dichlorohydrex polyethylene glycol

(nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(f) Aluminum dichlorohydrex polyethylene glycol

complex [see name with “complex”] ==== ==== ==== ==== ==== ==== Aluminum dichlorohydrex propylene glycol

(aerosol) Antiperspirant Antiperspirant Antiperspirant IIIS I 350.10(g) Aluminum dichlorohydrex propylene glycol

(nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(g) Aluminum dichlorohydrex propylene glycol

complex [see name with “complex”] ==== ==== ==== ==== ==== ==== Aluminum dihydroxy allantoinate [see aldioxa] ==== ==== ==== ==== ==== ==== Aluminum hydroxide Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Antimicrobial II Antifungal Acne IIE IIE 310.545(a)(1) Antacid Antacid Antacid I I 331.11(a)(2) Laxative Antidiarrheal Antidiarrheal IIIE IIIE 310.545(a)(3)(i) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer IIISE 310.545(a)(18)(iii)

Review Panel Report Drug Category ANPR PR FR

Miscellaneous internal Digestive aid Digestive aid (ippuad) IIIE n/a 310.545(a)(8)(ii) Miscellaneous internal Overindulgence in

alcohol/food Overindulgence

remedies (hangover)

I I Pending

Topical analgesic Skin protectant Skin protectant I I 347.10(b) Aluminum hydroxide (gel)

[see aluminum hydroxide gel] ==== ==== ==== ==== ==== ==== Aluminum hydroxide gel ==== Skin protectant Poison ivy/oak/

sumac n/a I 347.10(b)

Hemorrhoidal Anorectal Protectant (intrarectal)

I I 346.14(1)

Hemorrhoidal Anorectal Protectant (external) I I 346.14(1) Internal analgesic Internal analgesic Corrective I n/a n/a Miscellaneous internal Overindulgence in

alcohol/food Overindulgence

remedies (hangover)

I I Pending

Topical analgesic Skin protectant Skin protectant I I 347.10(b) Aluminum hydroxide sucrose powder hydrated Antacid Antacid Antacid I I 331.11(a)(2) Aluminum hydroxide-hexitol, stabilized polymer Antacid Antacid Antacid I I 331.11(a)(2) Aluminum hydroxide-magnesium carbonate,

co-dried gel Antacid Antacid Antacid I I 331.11(a)(2) Aluminum hydroxide-magnesium trisilicate,

co-dried gel Antacid Antacid Antacid I I 331.11(a)(2) Aluminum phosphate (gel)

[see aluminum phosphate gel] ==== ==== ==== ==== ==== ==== Aluminum phosphate gel Antacid Antacid Antacid I I 331.11(i)(1) Miscellaneous internal Hypophosphatemia/

hyperphosphatemia Hypophosphatemia IIS IIS 310.541(a)

Aluminum phosphate gel (when used as part of antacid combination)

Antacid Antacid Antacid I I 331.11(a)(4) Aluminum sesquichlorohydrate (aerosol) Antiperspirant Antiperspirant Antiperspirant IIIS I 350.10(h) Aluminum sesquichlorohydrate (nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(h) Aluminum sesquichlorohydrate propylene glycol

(nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(j) Aluminum sesquichlorohydrate propylene glycol

complex [see name without “complex”] ==== ==== ==== ==== ==== ==== Aluminum sesquichlorohydrate poylethylene

glycol (aerosol) Antiperspirant Antiperspirant Antiperspirant IIIS I 350.10(i) Aluminum sesquichlorohydrate poylethylene

glycol (nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(i) Aluminum sulfate Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(a)(22)(ii) Antiperspirant Antiperspirant Antiperspirant IIISE IIISE 310.545(a)(4) Miscellaneous external External analgesic Astringent IIIE n/a Pending Miscellaneous external Skin protectant Astringent IIIE I 347.12(b) Aluminum sulfate, buffered (aerosol) Antiperspirant Antiperspirant Antiperspirant IIIS IIIS 310.545(a)(4)(ii) Aluminum sulfate, buffered (nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 310.545(a)(4)(ii) Aluminum zirconium octachlorohydrate

(aerosol) Antiperspirant Antiperspirant Antiperspirant IIS IIS 310.502(a)(2)

Review Panel Report Drug Category ANPR PR FR

Aluminum zirconium octachlorohydrate (nonaerosol)

Antiperspirant Antiperspirant Antiperspirant I I 350.10(k) Aluminum zirconium octachlorohydrex glycine

(aerosol) Antiperspirant Antiperspirant Antiperspirant IIS IIS 310.502(a)(2) Aluminum zirconium octachlorohydrex glycine

(nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(1) Aluminum zirconium octachlorohydrex glycine

complex [see name without “complex”] ==== ==== ==== ==== ==== ==== Aluminum zirconium pentachlorohydrate

(aerosol) Antiperspirant Antiperspirant Antiperspirant IIS IIS 350.10(m) Aluminum zirconium pentachlorohydrate

(nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(m) Aluminum zirconium pentachlorohydrex glycine

(aerosol) Antiperspirant Antiperspirant Antiperspirant IIS IIS 310.502(a)(2) Aluminum zirconium pentachlorohydrex glycine

(nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(m) Aluminum zirconium pentachlorohydrex glycine

complex [see name without “complex”] ==== ==== ==== ==== ==== ==== Aluminum zirconium tetrachlorohydrate

(aerosol) Antiperspirant Antiperspirant Antiperspirant IIS IIS 310.502(a)(2) Aluminum zirconium tetrachlorohydrate

(nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(o) Aluminum zirconium tetrachlorohydrex glycine

(aerosol) Antiperspirant Antiperspirant Antiperspirant IIS IIS 310.502(a)(2) Aluminum zirconium tetrachlorohydrex glycine

(nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(p) Aluminum zirconium tetrachlorohydrex glycine

complex [see name without “complex”] ==== ==== ==== ==== ==== ==== Aluminum zirconium trichlorohydrate (aerosol) Antiperspirant Antiperspirant Antiperspirant IIS IIS 310.502(a)(2) Aluminum zirconium trichlorohydrate

(nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(q) Aluminum zirconium trichlorohydrex glycine

(aerosol) Antiperspirant Antiperspirant Antiperspirant IIS IIS 310.502(a)(2) Aluminum zirconium trichlorohydrex glycine

(nonaerosol) Antiperspirant Antiperspirant Antiperspirant I I 350.10(r) Aluminum zirconium trichlorohydrex glycine

complex [see name without “complex”] ==== ==== ==== ==== ==== ==== Aluminum sesquichlorohydrate propylene glycol

(aerosol) Antiperspirant Antiperspirant Antiperspirant IIIS I 350.10(r) Aminacrine hydrochloride Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Amiloxate n/a TEA Sunscreen n/a Amino acids Miscellaneous external Hair growth/loss Hair grower IISE IIE 310.527(a) Aminoacetic acid [see glycine] ==== ==== ==== ==== ==== ====

Review Panel Report Drug Category ANPR PR FR

Aminoacridine hydrochloride [see aminacrine hydrochloride]

==== ==== ==== ==== ==== ==== Aminobenzoic acid Internal analgesic Internal analgesic Analgesic adjuvant IISE IISE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antipyretic adjuvant IISE IISE 310.545(a) (23)(i) Internal analgesic Internal analgesic Antirheumatic

adjuvant IISE n/a 310.545(a) (23)(i)

Miscellaneous external Hair growth/loss Hair grower n/a IIE 310.527(a) Aminobenzoic acid (PABA) Topical analgesic Sunscreen Sunscreen I I 352.10(b) Aminophylline Cough/cold Cough/cold

(bronchodilator) Bronchodilator I IIS 310.545(a)(6)(iv)(A)

Ammonia Miscellaneous external Skin protectant Fever blister (topical) Defer n/a Pending Miscellaneous external External analgesic Fever blister (topical) Defer n/a Pending Ammonia solution, strong Miscellaneous external External analgesic Insect bite/sting IISE IISE 310.545(a)(18)(v)(A) Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(18)(v) Topical analgesic External analgesic Counterirritant I I Pending Topical analgesic External analgesic Fever blister (topical) n/a IISE 310.545(a)(10)(v) Ammonium alum [see alum, ammonium] ==== ==== ==== ==== ==== ==== Ammonium bromide Sedative Daytime sedative Sedative IISE IISE 310.519(a) Sedative Nighttime sleep aid Sleep aid IISE IISE [54 FR 6826] Ammonium carbonate Miscellaneous external External analgesic Fever blister (topical) Defer n/a Pending Miscellaneous external Skin protectant Fever blister (topical) Defer n/a Pending Ammonium chloride Cough/cold Cough/cold

(expectorant) Expectorant IIIE IIIE 310.545(a)(6)(iii)

Miscellaneous internal Menstrual/diuretic Diuretic I I Pending Oral cavity Oral health care Expectorant IIIE IIIE 310.545(a)(6)(iii) Sedative Stimulant Stimulant IIE IIE [39 FR 6104] Ammonium hydroxide Miscellaneous external External analgesic Insect bite/sting IIIE IIIE 310.545(a)(18)(v)(A) Miscellaneous external Skin protectant Insect bite/sting IIIE IIISE 310.545(a)(18)(v)(A) Amyl para-dimethylaminobenzoate [see

padimate A] ==== ==== ==== ==== ==== ==== Amylase Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(8)(ii)

Amyltricresols, secondary Antimicrobial II Antifungal Antifungal IIISE IIISE 310.545(a)(22)(ii) Oral cavity Oral health care Antimicrobial IIISE IIISE Pending Amylum [see starch] ==== ==== ==== ==== ==== ==== Amyltricresol, secondary [see amyltricresols,

secondary] ==== ==== ==== ==== ==== ==== Anion and cation exchange resins buffered Miscellaneous external External analgesic Poison ivy/oak/

sumac IIIE IIIE Pending

Miscellaneous external Skin protectant Poison ivy/oak/ sumac

IIIE IIIE 310.545(a)(10)(vii)(A)

Anise Miscellaneous internal Aphrodisiac Aphrodisiac n/a n/a 310.528(a) Anise oil Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Anise seed Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Antimony potassium tartrate Cough/cold Cough/cold

(expectorant) Expectorant IISE IISE 310.545(a)(6)(iii)

Review Panel Report Drug Category ANPR PR FR

Antipyrine Internal analgesic Internal analgesic Analgesic IIISE IIISE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antipyretic IIISE IIISE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antirheumatic IIISE not OTC 310.545(a)(23)(i) Oral cavity Oral health care Analgesic/anesthetic IISE IISE 310.545(a)(14) Ophthalmic Ophthalmic Analgesic/anesthetic IIS IIS 310.545(a)(21)(i) Topical analgesic Otic Analgesic/anesthetic IISE IISE [51 FR 28660] Aqua ammonia [see ammonium solution, strong] ==== ==== ==== ==== ==== ==== Aqueous coconut oil soap [see coconut oil soap,

aqueous] ==== ==== ==== ==== ==== ==== Arginine Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Aromatic oils Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external External analgesic Fever blister (topical) Defer n/a Pending Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Skin protectant Fever blister (topical) Defer n/a Pending Aromatic powder Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Aromatics Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Asafetida Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Asclepias tuberosa Miscellaneous internal Menstrual/diuretic Dysmenorrhea IISE IISE 310.545(a)(24)(i) Ascorbic acid Miscellaneous external Hair growth/loss Hair grower IIIE IIIE 310.527(a) Miscellaneous external Wart remover Wart remover IIIE IIIE [55 FR 33254] Miscellaneous external Corn/callus remover Corn/callus remover IISE IISE [55 FR 33261] Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Asparagus Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Aspergillus oryzae enzymes (except lactase

enzyme from aspergillus oryzae) Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Aspirin ==== External analgesic Fever blister (topical) n/a IIIE 310.545(a)(10)(v) ==== External analgesic Poison ivy/oak/

sumac n/a IIIE 310.545(a)(10)(vii)

Internal analgesic Internal analgesic Analgesic I I Pending Internal analgesic Internal analgesic Antipyretic I I Pending Internal analgesic Internal analgesic Antirheumatic I not OTC n/a Miscellaneous internal Menstrual/diuretic Analgesic I I Pending Miscellaneous internal Overindulgence in

alcohol/food Overindulgence

remedies (hangover)

I I Pending

Oral cavity Oral health care Analgesic/anesthetic I IIIE Pending Sedative Daytime sedative Sedative IIE IISE 310.519(a) Sedative Nighttime sleep aid Sleep aid IIE IIE [54 FR 6826] Topical analgesic External analgesic Analgesic/anesthetic IIIE IIIE 310.545(a)(10)(i) Aspirin, aluminum Internal analgesic Internal analgesic Analgesic n/a IISE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antipyretic IIIE IIIE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antirheumatic IIIE Not OTC 310.545(a)(23)(i) Aspirin, calcium Internal analgesic Internal analgesic Analgesic I I Pending Internal analgesic Internal analgesic Antipyretic I I Pending Internal analgesic Internal analgesic Antirheumatic I Not OTC n/a Miscellaneous internal Menstrual/diuretic Analgesic I I Pending

Review Panel Report Drug Category ANPR PR FR

Atropine ==== Menstrual/diuretic Menstrual n/a n/a 310.545(a)(24)(ii) ==== Internal analgesic Analgesic n/a n/a 310.545(a)(23)(ii) Hemorrhoidal Anorectal Anticholinergic

(external) IISE IISE 310.545(a)(26)(i)

Hemorrhoidal Anorectal Anticholinergic (intrarectal)

IISE IISE 310.545(a)(26)(i)

Atropine sulfate Cough/cold Cough/cold

(anticholinergic) Anticholinergic IIIE IIIE 310.533(a)

Laxative Antidiarrheal Antidiarrheal IIISE IIISE 310.545(a)(3)(i) Attapulgite, activated Laxative Antidiarrheal Antidiarrheal IIIE I 310.545(a)(3)(ii) Avobenzone ==== n/a Sunscreen n/a 1 352.10(a) Bacillus acidophilus Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Bacitracin Antimicrobial II Antibiotic First aid antibiotic n/a I 333.110(a) Antimicrobial II Antibiotic Skin wound antibiotic IIIE Defer n/a Bacitracin zinc Antimicrobial II Antibiotic First aid antibiotic n/a I 333.110(b) Balsam Peru [see Peruvian balsam] ==== ==== ==== ==== ==== ==== Balsam Peru oil [see Peruvian balsam oil] ==== ==== ==== ==== ==== ==== Barosma Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Basic aluminum carbonate gel Miscellaneous internal Hypophosphatemia/

hyperphosphatemia Hyperphosphatemia IIS IIS 310.541(a)

Basic fuchsin Antimicrobial II Antifungal Antifungal IIISE IIISE 310.545(a)(22)(ii) Bean Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Bearberry Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Bearberry (extract of uva ursi) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Bearberry fluidextract (extract of bearberry) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Beeswax ==== Insect bite/sting Insect bite/sting n/a n/a 310.545(a)(18)(v)(B) ==== Poison ivy/oak/sumac Poison ivy/oak/

sumac n/a n/a 310.545(a)(18)(vi)(B)

(bronchodilator) Bronchodilator

(inhalation) IISE IISE 310.545(a)(6)(iv)(A)

Cough/cold Cough/cold (anticholinergic)

Anticholinergic IIIE IIIE 310.533(a)

Miscellaneous external Corn/callus remover Corn/callus remover IISE IISE [55 FR 33261] Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Belladonna alkaloids (inhalation) atropa

belladonna/datura stramonium Cough/cold Cough/cold

(anticholinergic) Anticholinergic IISE IISE 310.533(a)

Belladonna extract Hemorrhoidal Anorectal Anticholinergic

(intrarectal) IISE IISE 310.545(a)(26)(i)

Hemorrhoidal Anorectal Anticholinergic (external)

IISE IISE 310.545(a)(26)(i)

Review Panel Report Drug Category ANPR PR FR

Belladonna leaves, powdered extract Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Bemotrizinol n/a TEA Sunscreen n/a Benzalkonium chloride Antimicrobial I Antimicrobial Antimicrobial soap n/a IISE Pending Antimicrobial I Antimicrobial First aid antiseptic n/a I Pending Antimicrobial I Antimicrobial Preoperative skin prep IIISE IIISE Pending Antimicrobial I Antimicrobial Skin antiseptic IIISE IIISE Pending Antimicrobial I Antimicrobial Skin wound cleanser I I Pending Antimicrobial I Antimicrobial Skin wound

protectant IIISE IIISE Pending

Antimicrobial I Antimicrobial Surgical hand scrub IIISE IIISE Pending Contraceptive/vaginal Vaginal Minor irritations IIISE Withdraw n/a Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer IIISE Pending Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff IIIE IIIE 310.545(a)(7)

Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external External analgesic Fever blister (topical) Defer n/a Pending Miscellaneous external External analgesic Insect bite/sting IISE IISE 310.545(a)(10)(vi) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Skin protectant Fever blister (topical) Defer n/a Pending Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(18)(v)(A) Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Benzethonium chloride Antimicrobial I Antimicrobial First aid antiseptic n/a I Pending Antimicrobial I Antimicrobial Surgical hand scrub IIISE IIISE Pending Antimicrobial I Antimicrobial Skin antiseptic IIISE IIISE Pending Antimicrobial I Antimicrobial Skin wound cleanser I I Pending Antimicrobial I Antimicrobial Skin wound

protectant IIISE IIISE Pending

Antimicrobial I Antimicrobial Antimicrobial soap n/a IISE Pending Antimicrobial I Antimicrobial Preoperative skin prep IISE IISE Pending Antimicrobial I Antimicrobial Health care personnel

handwash IIIE IIIE Pending

Antimicrobial II Antifungal Antifungal IIISE IIISE 310.545(a)(22)(ii) Miscellaneous external Antifungal Diaper rash Defer IISE 310.545(a)(22)(i) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/cradle cap IIIE IIIE 310.545(a)(7)

Miscellaneous external External analgesic Astringent IISE n/a 310.545(a)(18)(ii) Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IISE 310.545(a)(10)(vii)

sumac Defer IISE 310.545(a)(10)(vii)(A)

Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Oral cavity Oral health care Antimicrobial IIISE IIISE Pending Benzocaine Antimicrobial II Acne Acne IISE IISE 310.545(a)(1) Contraceptive/vaginal Vaginal Minor irritations IIIE Withdraw n/a Dental Relief of oral discomfort Oral mucosal

analgesic I I Pending

Dental Relief of oral discomfort Toothache relief IIIE IIIE Pending Hemorrhoidal Anorectal Anesthetic

(intrarectal) IIIE IIIE [55 FR 1779]

Hemorrhoidal Anorectal Anesthetic (external) I I 346.10(a) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external Boil treatment Boil treatment IISE IIISE 310.531(a) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Psoriasis IIE IIE [56 FR 63567]

Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external External analgesic Diaper rash Defer IISE 310.545(a)(10)(iv)

Review Panel Report Drug Category ANPR PR FR

Miscellaneous external External analgesic Fever blister (topical) Defer I Pending Miscellaneous external External analgesic Insect bite/sting n/a IIIE Pending Miscellaneous external Male genital

desensitizer Male genital

desensitizer I I 348.10(a)(1)

Miscellaneous external External analgesic Poison ivy/oak/ sumac

Defer I Pending

Miscellaneous external External analgesic Poison/ivy/oak/sumac Defer IIIE IISE (0.5-1.25%) Miscellaneous external Pediculicide Pediculicide IISE IISE 310.545(a)(25)(i) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Skin protectant Fever blister (topical) Defer DEF Pending Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer n/a 310.545(a)(10)(vii)

Miscellaneous external Wart remover Wart remover IISE IISE [55 FR 33254] Miscellaneous internal Weight control Anorectic I IISE Pending Oral cavity Oral health care Analgesic/anesthetic I I Pending Topical analgesic External analgesic Analgesic/anesthetic I I Pending Topical analgesic Otic Analgesic/anesthetic IISE IISE [51 FR 28660] Topical analgesic External analgesic Poison ivy/oak/

sumac IIIE n/a 310.545(a)(10)(vii)

Benzoic acid Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(a)(22)(ii) Miscellaneous external External analgesic Astringent IISE n/a n/a Miscellaneous external Hair growth/loss Hair grower IIE IIE 310.527(a) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Oral cavity Oral health care Antimicrobial IIIE IIIE Pending Benzoin tincture, compound Cough/cold Cough/cold

(expectorant) Expectorant

(topical/inhalant) IIIE IIIE 310.545(a)(6)(iii)

Dental Relief of oral discomfort Oral mucosal protectant

I I Pending

Benzoin, tincture Cough/cold Cough/cold

(expectorant) Expectorant n/a n/a 310.545(a)(6)(iii)

Benzonatate Cough/cold Cough/cold

(antitussive) Antitussive n/a I 310.533(a)

Benzoxiquine Antimicrobial II Antifungal Antifungal IISE IISE 310.545(a)(22)(ii) Benzoyl peroxide Antimicrobial II Acne Acne I I Pending Benzyl alcohol Dental Relief of oral discomfort Toothache relief IIISE IIISE Pending Dental Relief of oral discomfort Oral mucosal

analgesic IIISE I Pending

Hemorrhoidal Anorectal Anesthetic (external) IIIE I 346.10(b) Hemorrhoidal Anorectal Anesthetic

(intrarectal) IIIE IIIE [55 FR 1779]

Miscellaneous external Alcohols (topical) Antiseptic IIE Defer n/a Miscellaneous external External analgesic Fever blister (topical) Defer I Pending Miscellaneous external Male genital

desensitizer Male genital

desensitizer IISE IISE 310.545(a)(10)(iii)

Miscellaneous external External analgesic Poison ivy/oak/ sumac

Defer I Pending

Miscellaneous external Pediculicide Pediculicide IISE IISE 310.545(a)(25)(i) Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer IISE 310.545(a)(10)(vii)(A)

Oral cavity Oral health care Analgesic/anesthetic I I Pending Topical analgesic External analgesic Analgesic/anesthetic I I Pending Benzyl benzoate Miscellaneous external Pediculicide Pediculicide IISE IISE 310.545(a)(25)(i) Betaine hydrochloride Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Miscellaneous internal Stomach acidifier Stomach acidifier IIE IIE 310.540(a) Bicarbonate Antacid Antacid Antacid n/a n/a 331.11(b)

Review Panel Report Drug Category ANPR PR FR

Bicarbonate of soda [see sodium bicarbonate]

==== ==== ==== ==== ==== ==== Bile salts/acids Laxative Laxative Stimulant laxative IIISE IIISE 310.545(a)(12)(iv)(A) Biotin Miscellaneous external Hair growth/loss Hair grower n/a IISE 310.527(a) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Bisacodyl Laxative Laxative Stimulant laxative I I/IIIS Pending Bismuth aluminate Antacid Antacid Antacid I I 331.11(c)(1) Bismuth carbonate Antacid Antacid Antacid I I 331.11(c)(2) Bismuth oxide Hemorrhoidal Anorectal Protectant (external) IIIE IIIE 310.545(a)(26)(viii) Hemorrhoidal Anorectal Protectant (intrarectal) IIIE IIIE 310.545(a)(26)(viii) Bismuth sodium tartrate Miscellaneous external External analgesic Fever blister (topical) Defer IIISE 310.545(a)(10)(v) Miscellaneous external Skin protectant Fever blister (topical) Defer Defer Pending Miscellaneous internal Digestive aid Digestive aid (intestinal distress) IISE IISE 310.545(a)(8)(i) Bismuth subcarbonate Antacid Antacid Antacid I I 331.11(c)(3) Hemorrhoidal Anorectal Protectant (intrarectal) IIIE IIIE 310.545(a)(26)(viii) Hemorrhoidal Anorectal Protectant (external) IIIE IIIE 310.545(a)(26)(viii) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Bismuth subgallate Antacid Antacid Antacid I I 331.11(c)(4) Hemorrhoidal Anorectal Protectant (external) IIIE IIIE 310.545(a)(26)(viii) Hemorrhoidal Anorectal Protectant (intrarectal) IIIE IIIE 310.545(a)(26)(viii) Miscellaneous internal Deodorants for internal

use Internal deodorant IIIE I 357.810(a)

Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Bismuth subnitrate ==== Insect bite/sting Insect bite/sting n/a n/a 310.545(a)(18)(v)(B) ==== Poison ivy/oak/sumac Poison ivy/oak/sumac n/a n/a 310.545(a)(18)(vi)(B) ==== Skin protectant Fever blister (topical) n/a IISE 310.545(a)(10)(iv) ==== Skin protectant Poison ivy/oak/sumac n/a IISE 310.545(a)(10)(vii)(A) Antacid Antacid Antacid I I 331.11(c)(5) Hemorrhoidal Anorectal Protectant (external) IIS IIS 310.545(a)(26)(viii) Laxative Antidiarrheal Antidiarrheal IIISE IIISE Pending Miscellaneous external Anorectal Protectant (intrarectal) IIS IIS 310.545(a)(26)(viii) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer IISE Pending Topical analgesic Skin protectant Skin protectant IISE IISE Pending Bismuth subsalicylate Laxative Antidiarrheal Antidiarrheal IIIE IIIE 335.10(a) Laxative Antiemetic Antiemetic IIIE IIIE Defer (overindulgence) Miscellaneous internal Overindulgence in

alcohol/food Upset stomach I I Pending

Bisoctrizole n/a TEA Sunscreen n/a Bithionol Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii) Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(18)(vi)(A) Black radish powder Miscellaneous internal Digestive aid Digestive aid (intestinal distress) n/a n/a 310.545(a)(18)(ii) Blessed thistle (cnicus

benedictus) Miscellaneous internal Digestive aid Digestive aid (intestinal distress) n/a n/a 310.545(a)(18)(ii) Miscellaneous internal Menstrual/diuretic Menstrual n/a IISE 310.545(a)(24)(i)

Review Panel Report Drug Category ANPR PR FR

Bone marrow, red Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Borax [see sodium borate] ==== ==== ==== ==== ==== ==== Boric acid ==== Insect bite/sting Insect bite/sting n/a n/a 310.545(a)(18)(v)(B) ==== Poison ivy/oak/sumac Poison ivy/oak/sumac n/a n/a 310.545(a)(18)(vi)(B) ==== Skin protectant Fever blister (topical) n/a IISE 310.545(a)(18)(iv) ==== Skin protectant Poison ivy/oak/sumac n/a IISE 310.545(a)(10)(vii)(A) Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(a)(22)(ii) Contraceptive/vaginal Vaginal Astringent IIISE Withdraw n/a Contraceptive/vaginal Vaginal Alters vaginal pH IIISE Withdraw n/a Contraceptive/vaginal Vaginal Lowers surface tension mucolytic effects IIISE Withdraw n/a Contraceptive/vaginal Vaginal Minor irritations IIISE Withdraw n/a Hemorrhoidal Anorectal Antiseptic (external) IISE IISE 310.545(a)(26)(ii) Hemorrhoidal Anorectal Antiseptic (intrarectal) IISE IISE 310.545(a)(26)(ii) Miscellaneous external Antifungal Diaper rash Defer IISE 310.545(a)(22)(ii) Miscellaneous external Antimicrobial Diaper rash Defer IISE Pending Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic dermatitis IISE IISE 310.545(a)(7)

Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Diaper rash Defer IIS Pending Oral cavity Oral health care Antimicrobial IISE IISE Pending Ophthalmic Ophthalmic Anti-infective IIIE IIE 310.545(a)(21)(ii) Topical analgesic Skin protectant Skin protectant IISE IISE 310.545(a)(18)(i)(B) Bornelone Topical analgesic Sunscreen Sunscreen IIIE IIIE [64 FR 27682] Bornyl acetate Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant (topical) IIIE IIIE 310.545(a)(6)(ii)(B)

Boroglycerin Contraceptive/vaginal Vaginal Minor irritations IIISE Withdraw n/a Contraceptive/vaginal Vaginal Alters vaginal pH IIISE Withdraw n/a Contraceptive/vaginal Vaginal Astringent IIISE Withdraw n/a Contraceptive/vaginal Vaginal Lowers surface tension mucolytic effects IIISE Withdraw n/a Hemorrhoidal Anorectal Antiseptic (external) IISE IISE 310.545(a)(26)(ii) Hemorrhoidal Anorectal Antiseptic (intrarectal) IISE IISE 310.545(a)(26)(ii) Oral cavity Oral health care Antimicrobial IISE IISE Pending Boroglycerin glycerite [see

boroglycerin] ==== ==== ==== ==== ==== ==== Bran Laxative Laxative Bulk laxative I I Pending Bran, dietary [see bran] ==== ==== ==== ==== ==== ==== Bran, tablets [see bran] ==== ==== ==== ==== ==== ==== Bromopheniramine maleate Cough/cold Cough/cold

(antihistamine) Antihistamine I I 341.12(a)

Buchu Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Buchu powdered extract

(extract of buchu) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Buchu, extract Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Buckthorn Miscellaneous internal Digestive aid Digestive aid (intestinal distress) n/a n/a 310.545(a)(18)(ii) Buffered mixture

anion/cation exchange resin [see anion/cation exchange resins]

==== ==== ==== ==== ==== ====

Review Panel Report Drug Category ANPR PR FR

Butacaine sulfate Dental Relief of oral discomfort Oral mucosal

analgesic I I Pending

Dental Relief of oral discomfort Toothache relief IIISE IIISE Pending Butamben picrate ==== External analgesic Fever blister (topical) n/a I Pending ==== External analgesic Poison ivy/oak/

sumac n/a I Pending

Topical analgesic External analgesic Analgesic/anesthetic I I Pending Butylated hydroxyanisole ==== External analgesic Fever blister (topical) n/a n/a Pending ==== Skin protectant Fever blister (topical) n/a n/a Pending Caffeine Cough/cold Cough/cold

(miscellaneous) Corrective IIIE IIIE Pending

Internal analgesic Internal analgesic Analgesic adjuvant IIIE IIIE Pending Internal analgesic Internal analgesic Antipyretic adjuvant IIIE IIIE Pending Internal analgesic Internal analgesic Antirheumatic

adjuvant IIIE n/a Pending

Miscellaneous internal Menstrual/diuretic Analgesic adjuvant IIIE IIIE Pending Miscellaneous internal Menstrual/diuretic Diuretic I I Pending Miscellaneous internal Overindulgence in

alcohol/food Overindulgence

remedies (hangover)

I I Pending

Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Sedative Stimulant Stimulant I I 340.10 Calamine Hemorrhoidal Anorectal Astringent (external) I I 346.18(a) Hemorrhoidal Anorectal Astringent

(intrarectal) I I 346.18(a)

Hemorrhoidal Anorectal Protectant (intrarectal)

I I 346.14(b)(1)

Hemorrhoidal Anorectal Protectant (external) I I 346.14(b)(1) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(ii) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external External analgesic Insect bite/sting IISE IISE 310.545(a)(10)(vi) Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IISE 310.545(a)(10)(vii)

Miscellaneous external Skin protectant Skin protectant I I 347.10(c) Miscellaneous external Skin protectant Diaper rash Defer I Pending Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(10)(vi) Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer I 347.10(c)

Topical analgesic Skin protectant Skin protectant I I 347.10(c) Calamine (in combination only) Hemorrhoidal Anorectal Protectant

(intrarectal) I I 346.14(b)(1)

Hemorrhoidal Anorectal Protectant (external) I I 346.14(b)(1) Calcium Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Calcium acetate ==== Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external External analgesic Astringent IISE n/a Pending Calcium carbaspirin [see carbaspirin calcium] ==== ==== ==== ==== ==== ==== Calcium carbonate Antacid Antacid Antacid I I 331.11(d) Miscellaneous internal Digestive aid Digestive aid (ippuad) IIIE IIIE 310.545(a)(8)(i) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Calcium carbonate, precipitated Laxative Antidiarrheal Antidiarrheal IIIE IIIE 310.545(a)(3) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Calcium casinate Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20)

Review Panel Report Drug Category ANPR PR FR

Calcium gluconate Miscellaneous internal Digestive aid Digestive aid (intestinal distress) n/a n/a 310.545(a)(18)(ii) Calcium hydroxide Laxative Antidiarrheal Antidiarrheal IIIE IIIE 310.545(a)(3)(ii) Calcium iodide, anhydrous Cough/cold Cough/cold

(expectorant) Expectorant IISE IISE 310.545(a)(6)(iii)

Calcium lactate Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Calcium pantothenate Laxative Laxative Stimulant laxative IIIE IIIE 310.545(a)(12)(iv)(A) Miscellaneous external Wart remover Wart remover IIIE IIIE [55 FR 33254] Miscellaneous internal Menstrual/diuretic Premenstrual/menstrual period n/a IISE 310.545(a)(24)(i) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Calcium phosphate Antacid Antacid Antacid I I 331.11(d) Calcium phosphate, dibasic Dental Anticaries Anticavity agent IIE n/a [60 FR 52504] Internal analgesic Internal analgesic Corrective I n/a n/a Calcium phosphate, tribasic Antacid Antacid Antacid I I 331.11(d) Calcium polysulfide Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Calcium propionate Contraceptive/vaginal Vaginal Minor irritations I Withdraw n/a Calcium salicylate Internal analgesic Internal analgesic Analgesic n/a IISE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antirheumatic n/a Not OTC 310.545(a)(23)(i) Calcium salt (mono or dibasic) Antacid Antacid Antacid n/a n/a 331.11(i)(2) Calcium silicate Miscellaneous external External analgesic Fever blister (topical) Defer n/a Pending Miscellaneous external Skin protectant Fever blister (topical) Defer n/a Pending Calcium sucrose phosphate Dental Anticaries Anticavity agent IIE n/a 310.545(a)(2)(ii) Calcium thiosulfate Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Calcium undecylenate Antimicrobial II Antifungal Antifungal I I 333.210(f) Miscellaneous external Antifungal Diaper rash Defer IISE 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer IIISE Pending Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis/psoriasis IIISE IIISE 310.545(a)(7)

Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Calomel Laxative Laxative Stimulant laxative IIS IIS 310.545(a)(12)(iv)(A) Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Calomel (mercurous chloride) Miscellaneous external Antimicrobial First aid antiseptic n/a IIIE 310.545(a)(27)(i) Calomel [see mercuric chloride] ==== ==== ==== ==== ==== ==== Camphor Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Antimicrobial II Antifungal Antifungal IIE IIE 310.545(a)(22)(ii) Cough/cold Cold/cough

(antitussive) Antitussive (topical/inhalant) IIIE I 341.14(b)(1)

Cough/cold Cough/cold (expectorant)

Expectorant (lozenge) IIIE IIIE 310.545(a)(6)(iii)

Cough/cold Cough/cold (expectorant)

Expectorant (topical/inhalant) IIIE IIIE 310.545(a)(6)(iii)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (topical/inhalant)

IIIE IIIE [59 FR 43408]

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (lozenge) IIIE IIIE 310.545(a)(6)(ii)(A)

Review Panel Report Drug Category ANPR PR FR

Dental Relief of oral discomfort Oral mucosal analgesic

IISE IISE Pending

Hemorrhoidal Anorectal Analgesic (external) n/a I 346.16(a) Miscellaneous external Antifungal Diaper rash Defer IISE 310.545(a)(22)(ii) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external Boil treatment Boil treatment IISE IIISE 310.531(a) Miscellaneous external External analgesic Diaper rash Defer IISE 310.545(a)(10)(iv) Miscellaneous external External analgesic Insect bite/sting IISE I Pending Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer I Pending

Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Skin protectant Fever blister (topical) Defer Defer Pending Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(18)(v)(A) Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer IISE 310.545(a)(10)(vii)(A)

Miscellaneous external Wart remover Wart remover IISE IISE [55 FR 33254] Miscellaneous external External analgesic External analgesic

(less than 2.5%) I I Pending

Miscellaneous external External analgesic External analgesic (greater than 2.5%)

IISE IISE Pending

Oral cavity Oral health care Antimicrobial IISE IISE Pending Oral cavity Oral health care Analgesic/anesthetic IISE IISE 310.545(a)(14) Topical analgesic External analgesic Counterirritant I I Pending Topical analgesic External analgesic Analgesic/anesthetic I I Pending Topical analgesic External analgesic External analgesic I I Pending Topical analgesic Sunscreen Sunscreen IISE IISE [64 FR 27682] Topical analgesic External analgesic Antipyretic n/a I Pending Camphor (>3-11%) Miscellaneous external External analgesic Fever blister (topical) Defer IISE 310.545(a)(10)(v) Camphor (0.1-3%) Miscellaneous external External analgesic Fever blister (topical) Defer I Pending Camphor (greater than 3-11%) Hemorrhoidal Anorectal Counterirritant

(intrarectal) IISE IISE 310.545(a)(26)(iv)

Hemorrhoidal Anorectal Counterirritant (external)

IISE IISE 310.545(a)(26)(iv)

Camphor gum Miscellaneous external External analgesic Astringent IISE n/a n/a Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Camphorated metacresol ==== External analgesic Fever blister (topical) n/a I Pending ==== External analgesic Poison ivy/oak/

sumac n/a I Pending

Antimicrobial II Antifungal Antifungal IIISE IIISE 310.545(a)(22)(iv) Miscellaneous external Male genital

desensitizer Male genital

desensitizer n/a IISE 310.545(a)(10)(iii)

Topical analgesic External analgesic Analgesic/anesthetic IIISE I Pending Camphorated oil Miscellaneous external Camphorated oil Counterirritant IIS n/a 310.502(a)(4) Candelillia wax [see wax, candelilla] ==== ==== ==== ==== ==== ==== Candicidin Antimicrobial II Antifungal Anticandidial IISE IISE 310.545(a)(22)(ii) Cantharides Miscellaneous internal Aphrodisiac Aphrodisiac IISE IISE 310.528(a) Capsaicin Miscellaneous external External analgesic Fever blister (topical) Defer IISE 310.545(a)(10)(v) Topical analgesic External analgesic Counterirritant I I Pending Capsicum Dental Relief of oral discomfort Counterirritant

(external) IIIE IIIE Pending

Dental Relief of oral discomfort Toothache relief IISE IISE Pending Miscellaneous external External analgesic Fever blister (topical) Defer IISE 310.545(a)(10)(v) Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(8)(ii) Topical analgesic External analgesic Counterirritant I I Pending

Review Panel Report Drug Category ANPR PR FR

Capsicum oleoresin Miscellaneous external External analgesic Fever blister (topical) Defer IISE 310.545(a)(10)(v) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Topical analgesic External analgesic Counterirritant I I Pending Capsicum, fluid extract of Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Captan Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff IIIE IIIE 310.545(a)(7)

Caramiphen edisylate Cough/cold Cold/cough

(antitussive) Antitussive IIIE IIIE [52 FR 30054]

Carbamide peroxide Miscellaneous external External analgesic Fever blister (topical) Defer Defer Pending Miscellaneous external Skin protectant Fever blister (topical) Defer Defer Pending Oral cavity Oral health care Debriding agent III III Pending Oral cavity Oral health care Antimicrobial IIIE IIIE Pending Carbamide peroxide (in anhydrous glycerin) Dental Oral mucosal injury Wound cleanser I I Pending Dental Oral mucosal injury Wound healing agent IIIE IIIE 310.534(a) Carbamide peroxide 6.5% (in anhydrous

glycerin) Topical analgesic Otic Ear wax softening

agent I I 344.10

Carbaspirin calcium Internal analgesic Internal analgesic Antipyretic I I Pending Internal analgesic Internal analgesic Analgesic I I Pending Internal analgesic Internal analgesic Antirheumatic I Not OTC n/a Miscellaneous internal Menstrual/diuretic Analgesic I I Pending Carbetapentane citrate Cough/cold Cold/cough

(antitussive) Antitussive IIIE IIIE [52 FR 30054]

Carbon Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Carbon dioxide, released Laxative Laxative Laxative I I Pending Carboxymethylcellulose Antacid Antacid Antacid IIIE IIIE [39 FR 19874] Carboxymethylcellulose sodium Laxative Antidiarrheal Antidiarrheal IIIE IIIE 310.545(a)(3)(i) Laxative Laxative Bulk laxative I I Pending Miscellaneous internal Weight control Anorectic IIIE IISE 310.545(a)(20) Ophthalmic Ophthalmic Demulcent I I 349.12(a)(1) Carnauba wax [see wax, carnauba] ==== ==== ==== ==== ==== ==== Carrageenan Miscellaneous internal Weight control Anorectic IIIE IISE 310.545(a)(20) Carrageenan (degraded) [see carrageenan,

degraded] ==== ==== ==== ==== ==== ==== Carrageenan (native) [see carrageenan, native] ==== ==== ==== ==== ==== ==== Carrageenan, degraded Laxative Laxative Bulk laxative IIS IIS 310.545(a)(12)(i) Carrageenan, native Laxative Laxative Bulk laxative IIIE IIIE 310.545(a)(12)(i) Casanthranol Laxative Laxative Stimulant laxative I I/IIIS Pending Cascara fluidextract aromatic [see cascara

fluidextract, aromatic] ==== ==== ==== ==== ==== ==== Cascara fluidextract, aromatic Laxative Laxative Stimulant laxative I I/IIIS 310.545(a)(12)(iv)(C) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Cascara sagrada Laxative Laxative Stimulant laxative I I/IIIS 310.545(a)(12)(iv)(C)

Review Panel Report Drug Category ANPR PR FR

Cascara sagrada bark [see cascara sagrada]

==== ==== ==== ==== ==== ==== Cascara sagrada extract Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Cascarasagrada extract Laxative Laxative Stimulant laxative I I/IIIS 310.545(a)(12)(iv)(C) Cascarasagrada fluid extract Laxative Laxative Stimulant laxative I I/IIIS 310.545(a)(12)(iv)(C) Casein Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a n/a Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer Withdraw n/a Castor oil Laxative Laxative Stimulant laxative I I Pending Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Miscellaneous external Wart remover Wart remover IISE IISE [55 FR 33254] Catechu, tincture Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Catnip Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Cedar leaf oil Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant (topical) IIIE IIIE 310.545(a)(6)(ii)(B)

Cellulase Miscellaneous internal Digestive aid Digestive aid (intestinal distress) IIIE IIIE 310.545(a)(8)(i) Miscellaneous internal Digestive aid Digestive aid (ippuad) IIE IIE 310.545(a)(8)(i) Cellulose Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a n/a Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a n/a Cellulose, microporous Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer IIISE Pending Cetalkonium chloride Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii) Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(18)(vii)(A) Oral cavity Oral health care Antimicrobial IIIE IIIE Pending Cetyl alcohol ==== Insect bite/sting Insect bite/sting n/a n/a 310.545(a)(18)(v)(B) ==== Poison ivy/oak/sumac Poison ivy/oak/sumac n/a n/a 310.545(a)(18)(vi)(B) ==== Skin protectant Skin protectant n/a n/a 310.545(a)(18)(i)(B) Miscellaneous external External analgesic Fever blister (topical) n/a n/a n/a Miscellaneous external Skin protectant Fever blister (topical) Defer n/a Pending Cetylpyridinium chloride ==== Antigingivitis/antiplaque Antigingivitis/antiplaque I ==== Pending Oral cavity Oral health care Antimicrobial IIISE IIISE Pending Chamomile flowers Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Charcoal, activated Antacid Antacid Antacid IIE IIE [39 FR 19873] Laxative Antidiarrheal Antidiarrheal IIIE IIIE 310.545(a)(3)(ii) Miscellaneous internal Deodorants for internal use Internal deodorant IIIE IIIE [55 FR 19864] Miscellaneous internal Digestive aid Digestive aid (intestinal distress) IIIE IIIE 310.545(a)(8)(iii) Miscellaneous internal Overindulgence in

alcohol/food Minimize hangover symptoms IIIE IIIE [48 FR 32873]

Miscellaneous internal Poison treatment Poison absorbent n/a I Pending Miscellaneous internal Acute toxic ingestion Poison treatment I I Pending Charcoal, wood Miscellaneous internal Digestive aid Digestive aid (intestinal distress) IIIE IIIE 310.545(a)(18)(ii) Chlophedianol hydrochloride Cough/cold Cold/cough (antitussive) Antitussive n/a I 341.14(a)(1)

Review Panel Report Drug Category ANPR PR FR

Chloral hydrate ==== External analgesic Fever blister (topical) n/a IIE 310.545(a)(10)(v) Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IIE 310.545(a)(10)(vii)

Miscellaneous external Skin protectant Poison ivy/oak/ sumac

Defer IISE 310.545(a)(10)(vii)(A)

Topical analgesic External analgesic Analgesic/anesthetic IIE IIE 310.545(a)(10)(i) Topical analgesic External analgesic Counterirritant n/a n/a 310.545(a)(10)(ii) Chlorcyclizine hydrochloride Cough/cold Cough/cold

(antihistamine) Antihistamine n/a I 341.12(b)

Chlorhydroxyquinoline [see cloxyquin] ==== ==== ==== ==== ==== ==== Chlorobutanol ==== External analgesic Fever blister (topical) n/a IIIE 310.545(a)(10)(v) ==== External analgesic Poison ivy/oak/

sumac n/a IIIE 310.545(a)(10)(vii)

Miscellaneous external Alcohols (topical) Antiseptic IIE Defer n/a Miscellaneous external Corn/callus remover Corn/callus remover IISE IISE [55 FR 33261] Topical analgesic External analgesic Analgesic/anesthetic IIIE IIIE 310.545(a)(10)(i) Chloroform Cough/cold Cough/cold

(expectorant) Expectorant IISE IISE 310.545(a)(6)(iii)

Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Chlorophenothane Miscellaneous external Pediculicide Pediculicide IISE IISE 310.545(a)(25)(i) Chlorophyll [see chlorophyllin copper complex] ==== ==== ==== ==== ==== ==== Chlorophyllin Dental Relief of oral discomfort Oral mucosal

analgesic n/a IIISE Pending

Chlorophyllin copper complex Dental Oral mucosal injury Wound healing agent IIIE IIIE 310.534(a) Miscellaneous internal Deodorants for internal

use Internal deodorant IIIE I 357.810(b)

Oral cavity Oral health care Antimicrobial IIIE IIIE Pending Chlorophyllins, water-soluble [see chlorophyllin

copper complex] ==== ==== ==== ==== ==== ==== Chlorothymol Antimicrobial II Antifungal Antifungal IIISE IIISE 310.545(a)(22)(ii) Chloroxlyneol Antimicrobial I Antimicrobial First aid antiseptic n/a IIIE Pending Antimicrobial I Antimicrobial Antimicrobial soap IIISE IIISE Pending Antimicrobial I Antimicrobial Preoperative skin prep IIISE IIISE Pending Antimicrobial I Antimicrobial Skin wound cleanser IIISE IIISE Pending Antimicrobial I Antimicrobial Skin wound

protectant IIISE IIISE Pending

Antimicrobial I Antimicrobial Skin antiseptic IIISE IIISE Pending Antimicrobial I Antimicrobial Surgical hand scrub IIISE IIISE Pending Antimicrobial I Antimicrobial Health care personnel

handwash IIIE IIIE Pending

Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(a)(22)(iv) Miscellaneous external Antifungal Diaper rash Defer IISE 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer IIISE Pending Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis IIISE IIISE 310.545(a)(7)

Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Ingrown toenail Ingrown toenail IISE IISE 310.538(a) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Chlorpheniramine maleate Cough/cold Cough/cold

(antihistamine) Antihistamine I I 341.12(c)

Miscellaneous external External analgesic Poison ivy/oak/ sumac

Defer IISE 310.545(a)(10)(vii)

Miscellaneous external Skin protectant Poison ivy/oak/ sumac

Defer IISE 310.545(a)(10)(vii)(A)

Review Panel Report Drug Category ANPR PR FR

Chlorprophenpyridamine maleate Miscellaneous internal Menstrual/diuretic Menstrual n/a IISE 310.545(a)(24)(i) Chlortetracycline hydrochloride Antimicrobial II Antibiotic First aid antibiotic n/a I 333.110(c) Antimicrobial II Antibiotic Skin wound antibiotic IIE Defer n/a Antimicrobial II Antibiotic Skin wound protectant I Defer n/a Chloxyquin Antimicrobial II Acne Acne IISE IISE 310.545(a)(1) Cholecalciferol Hemorrhoidal Anorectal Wound healing agent (external) IIIE IIIE 310.545(a)(26)(x) Hemorrhoidal Anorectal Wound healing agent (intrarectal) IIIE IIIE 310.545(a)(26)(x) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer IIISE Pending Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Cholesterol Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Choline Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Choline salicylate Internal analgesic Internal analgesic Analgesic I I Pending Internal analgesic Internal analgesic Antipyretic I I Pending Internal analgesic Internal analgesic Antirheumatic I Not OTC n/a Miscellaneous internal Menstrual/diuretic Analgesic I I Pending Chondrus Miscellaneous internal Weight control Anorectic IIIE IISE 310.545(a)(20) Cimicifuga racemosa Miscellaneous internal Menstrual/diuretic Dysmenorrhea IISE IISE 310.545(a)(24)(i) Cinnamedrine hydrochloride Miscellaneous internal Menstrual/diuretic Smooth muscle relaxant IIIE IIIE Pending Cinnamon oil Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Cinnamon tincture Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Cinoxate Topical analgesic Sunscreen Sunscreen I I 352.10(c) Citric acid Contraceptive/vaginal Vaginal Alters vaginal pH IIIE Withdraw n/a Dental Relief of oral discomfort Tooth desensitizer (in combination

only) IIIE IIIE Pending

Internal analgesic Internal analgesic Corrective I n/a n/a Miscellaneous internal Digestive aid Digestive aid (intestinal distress) IIIE n/a 310.545(a)(18)(ii) Miscellaneous internal Digestive aid Digestive aid (ippuad) IIIE n/a 310.545(a)(18)(ii) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Citric acid/salt Antacid Antacid Antacid I I 331.11(e) Citrus pectin Miscellaneous internal Digestive aid Digestive aid (intestinal distress) n/a n/a 310.545(a)(18)(ii) Climbazole n/a TEA Dandruff n/a Clioquinol Antimicrobial II Antifungal Antifungal I I 333.210(a) Cloflucarban Antimicrobial I Antimicrobial Skin antiseptic n/a IISE Pending Antimicrobial I Antimicrobial Skin wound protectant IISE IISE Pending Antimicrobial I Antimicrobial First aid antiseptic IISE IISE Pending Antimicrobial I Antimicrobial Antimicrobial soap IIIS IIIS Pending Antimicrobial I Antimicrobial Skin wound cleanser IISE IIISE Pending Antimicrobial I Antimicrobial Preoperative skin prep IISE IISE Pending Antimicrobial I Antimicrobial Surgical hand scrub IISE IISE Pending Antimicrobial I Antimicrobial Health care personnel handwash IIISE IIISE Pending Clotrimazole n/a n/a Antifungal n/a I [67 FR 5942]

Review Panel Report Drug Category ANPR PR FR

Clove Miscellaneous internal Smoking deterrent Smoking deterrent IIE IIE 310.544(d) Clove oil Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Cloves, ground [see clove] ==== ==== ==== ==== ==== ==== Cnicus benedictus Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Coal tar Antimicrobial II Acne Acne IISE IISE 310.545(a)(1) Antimicrobial II Antifungal Antifungal IISE IISE 310.545(a)(22)(ii) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Psoriasis I I 358.710(c)(1)

Coal tar (shampoo) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff I I 358.710(a)(1)

Coal tar (nonshampoo) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Seborrheic dermatitis IIIE I 358.710(b)(1)

Cocoa butter ==== Skin protectant Diaper rash Defer IIISE 310.545(a)(18)(iii) ==== Skin protectant Fever blister (topical) n/a I Pending Hemorrhoidal Anorectal Protectant (external) I I 346.14(2) Hemorrhoidal Anorectal Protectant (intrarectal) I I 346.14(2) Topical analgesic Skin protectant Skin protectant I I 347.10(d) Cocoa butter substitutes [see hard fat] ==== ==== ==== ==== ==== ==== Coconut oil soap, aqueous Miscellaneous external Pediculicide Pediculicide IISE IISE 310.545(a)(25)(i) Cod liver oil ==== Skin protectant Skin protectant n/a n/a 347.10(e) Cough/cold Cold/cough

(antitussive) Antitussive IIIE IIIE [52 FR 30054]

Hemorrhoidal Anorectal Wound healing agent (intrarectal)

IIISE IIISE 310.545(a)(26)(x)

Hemorrhoidal Anorectal Wound healing agent (external)

IIISE IIISE 310.545(a)(26)(x)

(antitussive) Antitussive I I 341.14(a)(2)(i)

Internal analgesic Internal analgesic Analgesic IISE IISE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antipyretic IISE IISE 310.545(a)(23)(i) Miscellaneous internal Menstrual/diuretic Analgesic IIS IISE 310.545(a)(24)(i) Codeine phosphate Cough/cold Cold/cough

(antitussive) Antitussive I I 341.14(a)(2)(ii)

Internal analgesic Internal analgesic Analgesic IISE n/a 310.545(a)(23)(i) Codeine sulfate Cough/cold Cold/cough

(antitussive) Antitussive I I 341.14(a)(2)(iii)

Internal analgesic Internal analgesic Analgesic IISE n/a 310.545(a)(23)(i) Codeine, alkaloid [see codeine] ==== ==== ==== ==== ==== ==== Collinsonia extract Hemorrhoidal Anorectal Anorectal (external) IISE IISE 310.545(a)(26)(vii) Hemorrhoidal Anorectal Anorectal (intrarectal) IISE IISE 310.545(a)(26)(vii) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i)

Review Panel Report Drug Category ANPR PR FR

Colloidal oatmeal ==== Skin protectant Skin protectant n/a n/a 347.10(f) ==== Skin protectant Poison ivy/oak/sumac n/a I 347.10(f) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff IIE IIE 310.545(a)(7)

Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Skin protectant Astringent IISE IIE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Diaper rash Defer IISE Pending Colocynth Laxative Laxative Stimulant laxative IIS IIS 310.545(a)(12)(iv)(A) Compound white pine syrup [see

white pine syrup, compound] ==== ==== ==== ==== ==== ==== Copper Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Copper gluconate Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Copper oleate Miscellaneous external Pediculicide Pediculicide IISE IISE 310.545(a)(25)(i) Copper undecylenate Antimicrobial II Antifungal Antifungal I I 333.210(f) Coriander Miscellaneous internal Smoking deterrent Smoking deterrent IIE IIE 310.544(d) Coriander, ground [see coriander] ==== ==== ==== ==== ==== ==== Corn oil Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Corn oil, aqueous emulsion Miscellaneous internal Cholecystokinetic Cholecystokinetic I I 357.210(a) Corn silk Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Corn silk, potassium extract Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Corn starch [see starch, corn] ==== ==== ==== ==== ==== ==== Corn syrup Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Couch grass Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Creosote Dental Relief of oral discomfort Toothache relief IIIE IIIE Pending Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii)(A) Creosote, beechwood ==== Skin protectant Poison ivy/oak/sumac n/a IISE 310.545(a)(18)(vi) Cough/cold Cold/cough

(antitussive) Antitussive IIIE IIIE [52 FR 30054]

Cough/cold Cough/cold (expectorant)

Expectorant IIIE IIIE 310.545(a)(6)(iii)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (oral) IIIE IIIE 310.545(a)(6)(ii)(A)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (topical) IIIE IIIE 310.545(a)(6)(ii)(B)

Dental Relief of oral discomfort Toothache relief IIISE IIISE Pending Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii) Cresol Antimicrobial II Antifungal Antifungal IIISE IIISE 310.545(a)(22)(iv) Dental Relief of oral discomfort Toothache relief IIISE IIISE Pending Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Astringent Antiseptic IIE Defer n/a Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Oral cavity Oral health care Antimicrobial IIS IISE Pending Oral cavity Oral health care Analgesic/anesthetic IISE IISE 310.545(a)(14) Oral cavity Relief of oral discomfort Oral mucosal analgesic IIISE IIISE Pending Cresol saponated Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Psoriasis IIE IIE 310.545(a)(7)

Review Panel Report Drug Category ANPR PR FR

Cupric sulfate Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Cyanocobalamin (vitamin B12) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Cyclizine hydrochloride Laxative Antiemetic Antiemetic I I 336.10(a) Cyclomethycaine sulfate ==== External analgesic Fever blister (topical) n/a IIIE 310.545(a)(10)(v) ==== External analgesic Poison ivy/oak/

sumac n/a IIIE 310.545(a)(10)(vii)

Internal analgesic External analgesic Analgesic/anesthetic IIIE IIIE 310.545(a)(10)(i) Cysteine hydrochloride Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer IIISE 310.545(a)(18)(iii) Cystine Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Danthron Laxative Laxative Stimulant laxative I IIS 310.545(a)(12)(iv)(B) D-Calcium pantothenate [see calcium

pantothenate] ==== ==== ==== ==== ==== ==== Dehydrocholic acid Laxative Laxative Stimulant laxative I I Pending Miscellaneous internal Digestive aid Digestive aid (intestinal

distress) IIE IIE 310.545(a)(8)(i)

Miscellaneous internal Digestive aid Digestive aid (ippuad) IIE IIE 310.545(a)(8)(i) Denatonium benzoate Miscellaneous external Nailbiting/thumbsucking Nailbiting/thumbsucking

deterrent IIIE IIIE 310.536(a)

Dequalinium chloride Oral cavity Oral health care Antimicrobial IIISE IIISE Pending Desoxyephedrine, L-[see

levomethamphetamine] ==== ==== ==== ==== ==== ==== Dexbromopheniramine maleate Cough/cold Cough/cold (antihistamine) Antihistamine IIISE I 341.12(d) Cough/cold Cough/cold (antihistamine) Antihistamine n/a I 341.12(f) Dexchlorpheniramine maleate Cough/cold Cough/cold (antihistamine) Antihistamine n/a I 341.12(e) Dexpanthenol ==== External analgesic Poison ivy/oak/

sumac n/a IIIE 310.545(a)(10)(vii)

Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external External analgesic Insect bite/sting n/a IIIE Pending Miscellaneous external Hair growth/loss Hair grower n/a IIE 310.527(a) Miscellaneous external Skin protectant Diaper rash Defer IIISE Pending Dextran 70 Ophthalmic Ophthalmic Demulcent I I 349.12(b) Dextromethorphan Cough/cold Cold/cough (antitussive) Antitussive I I 341.14(a)(3) Dextromethorphan hydrobromide Cough/cold Cough/cold (antitussive) Antitussive n/a n/a 341.14(a)(4) Dextrose Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Diastase Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Diastase malt Miscellaneous internal Digestive aid Digestive aid (intestinal

distress) n/a n/a 310.545(a)(18)(ii)

Dibenzothiophene Antimicrobial II Acne Acne IIS IIS 310.545(a)(1)

Review Panel Report Drug Category ANPR PR FR

Dibucaine ==== External analgesic Poison ivy/oak/

sumac n/a I Pending

Hemorrhoidal Anorectal Anesthetic (intrarectal)

IIISE IIISE [55 FR 1779]

Hemorrhoidal Anorectal Anesthetic (external) IIIS I 346.10(d) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer IISE 310.545(a)(10)(iv) Miscellaneous external External analgesic Fever blister (topical) Defer I Pending Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Oral cavity Oral health care Analgesic/anesthetic IIS IIS 310.545(a)(14) Topical analgesic External analgesic Analgesic/anesthetic I I Pending Dibucaine hydrochloride ==== External analgesic Fever blister (topical) n/a I Pending ==== External analgesic Poison ivy/oak/

sumac n/a I Pending

Hemorrhoidal Anorectal Anesthetic (external) IIIS I 346.10(c) Hemorrhoidal Anorectal Anesthetic

(intrarectal) IIISE IIISE [55 FR 1779]

Oral cavity Oral health care Analgesic/anesthetic IIS IIS 310.545(a)(14) Topical analgesic External analgesic Analgesic/anesthetic I I Pending Dicalcium phosphate dihydrate [see calcium

phosphate, dibasic] ==== Gingivitis/plaque Gingivitis/antiplaque n/a IIIE Pending Dichlorodiphenyl trichloroethane [see

chorophenothane] ==== ==== ==== ==== ==== ==== Dichlorophen Antimicrobial II Antifungal Antifungal IIISE IIISE 310.545(a)(22)(ii) Miscellaneous external Hair growth/loss Hair grower IISE n/a 310.527(a) Diethanolamine methoxycinnamate Topical analgesic Sunscreen Sunscreen I I 310.545(a)(29) Diethanolamine p-methoxy-cinnamate [see

diethanolamine methoxycinnamate] ==== ==== ==== ==== ==== ==== Diethylhexyl butamido triazone (Uvasorb HEB) n/a TEA Sunscreen n/a Digalloyltrioleate Topical analgesic Sunscreen Sunscreen I I 310.545(a)(29) Dihydroxyaluminum aminoacetate Antacid Antacid Antacid I I 331.11(a)(3) Dihydroxyaluminum aminoacetic acid Antacid Antacid Antacid n/a n/a 331.11(a)(3) Internal analgesic Internal analgesic Corrective I n/a n/a Dihydroxyaluminum sodium carbonate Antacid Antacid Antacid I I 331.11(a)(5) Internal analgesic Internal analgesic Corrective I n/a n/a Miscellaneous internal Digestive aid Digestive aid (ippuad) IIIE IIIE 310.545(a)(8)(i) Dimenhydrinate Laxative Antiemetic Antiemetic I I 336.10(b) Dimethicone ==== Skin protectant Diaper rash n/a I Pending ==== Skin protectant Fever blister (topical) n/a I Pending Topical analgesic Skin protectant Skin protectant I I 347.10(g) Dimethisoquin hydrochloride ==== External analgesic Poison ivy/oak/

sumac n/a I Pending

==== External analgesic Fever blister (topical) n/a I Pending Topical analgesic External analgesic Analgesic/anesthetic I I Pending Dioxybenzone Topical analgesic Sunscreen Sunscreen I I 352.10(e) Diperodon Hemorrhoidal Anorectal Anesthetic

(intrarectal) IIISE IIISE 310.545(a)(26)(vi)

Hemorrhoidal Anorectal Anesthetic (external) IIE IIIE 310.545(a)(26)(vi)

Review Panel Report Drug Category ANPR PR FR

Diperodon hydrochloride Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii)(A) Miscellaneous external Corn/callus remover Corn/callus remover IISE IISE [55 FR 33261] Diphenhydramine citrate Cough/cold Cough/cold (antitussive) Antitussive n/a n/a 341.14(a)(5) Cough/cold Cough/cold (antihistamine) Antihistamine n/a n/a 341.12(f) Sedative Nighttime sleep aid Sleep aid n/a n/a 338.10(b) Diphenhydramine hydrochloride ==== External analgesic Fever blister (topical) n/a I Pending Cough/cold Cough/cold (antitussive) Antitussive I IIIE 341.14(a)(6) Cough/cold Cough/cold (antihistamine) Antihistamine I I 341.12(g) Laxative Antiemetic Antiemetic IIIE IIIE 336.10(c) Miscellaneous external External analgesic Poison ivy/oak/sumac Defer I Pending Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(18)(vi)(A) Sedative Daytime sedative Sedative IISE IISE 310.519(a) Sedative Nighttime sleep aid Sleep aid IIISE IIISE 336.10(a) Topical analgesic External analgesic Analgesic/anesthetic I I Pending Diphenhydramine monocitrate [see

diphenhydramine citrate] ==== ==== ==== ==== ==== ==== Dipropylene glycol salicylate Topical analgesic Sunscreen Sunscreen IIISE IIISE [64 FR 27682] DL-Methionine [see racemethionine] ==== ==== ==== ==== ==== ==== Docusate calcium Laxative Laxative Stool softener I I Pending Docusate potassium Laxative Laxative Stool softener I I Pending Docusate sodium Contraceptive/vaginal Vaginal Lowers surface tension

mucolytic effects I Withdraw n/a

Laxative Laxative Stool softener I I Pending Miscellaneous external Pediculicide Pediculicide IISE IISE 310.545(a)(25)(i) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Dodecaethylene glycol monolaurate Contraceptive/vaginal Contraceptive (vaginal) Contraceptive IIIE Withdraw 310.545(a)(28) Dodecaethyleneglycol monolaurate [see

dodecaethylene glycol monolaurate] ==== ==== ==== ==== ==== ==== Dog grass Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Dog grass extract Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Domiphen bromide Oral cavity Oral health care Antimicrobial IIISE IIISE Pending Don qual Miscellaneous internal Aphrodisiac Aphrodisiac IISE IISE 310.528(a) Doxylamine succinate Cough/cold Cough/cold (antihistamine) Antihistamine I I 341.12(h) Sedative Daytime sedative Sedative IISE IISE 310.519(a) Sedative Nighttime sleep aid Sleep aid IIISE IIISE [54 FR 6826] Duodenal substance Miscellaneous internal Digestive aid Digestive aid (intestinal

distress) IISE IISE 310.545(a)(8)(i)

Dyclonine hydrochloride ==== External analgesic Fever blister (topical) n/a I Pending ==== External analgesic Poison ivy/oak/sumac n/a I Pending Hemorrhoidal Anorectal Anesthetic (external) IIIE I 346.10(e) Hemorrhoidal Anorectal Anesthetic (intrarectal) IIIE IIIE [55 FR 1779] Oral cavity Oral health care Analgesic/anesthetic I I Pending Topical analgesic External analgesic Analgesic/anesthetic I I Pending

Review Panel Report Drug Category ANPR PR FR

E. coli vaccines Hemorrhoidal Anorectal Anorectal (External) IISE IISE 310.545(a)(26)(vii) Hemorrhoidal Anorectal Anorectal (intrarectal) IISE IISE 310.545(a)(26)(vii) Edetate disodium Contraceptive/vaginal Vaginal Minor irritations IIISE Withdraw n/a Dental Relief of oral discomfort Tooth desensitizer (in

combination only) IISE IISE Pending

Edetate sodium Contraceptive/vaginal Vaginal Minor irritations IIISE Withdraw n/a Elaterin resin Laxative Laxative Stimulant laxative IIS IIS 310.545(a)(12)(iv)(A) Elecampane Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Elm bark Cough/cold Cough/cold (antitussive) Antitussive IIIE IIIE [52 FR 30054] Oral cavity Oral health care Demulcent I I Pending Endothermic hectorite [see

hectorite] ==== ==== ==== ==== ==== ==== Ensulizole Topical analgesic Sunscreen Sunscreen I I 352.10(n) Enzacamene n/a TEA Sunscreen n/a Ephedrine Cough/cold Cough/cold (bronchodilator) Bronchodilator I I 341.16(a) Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(topical/inhalant) I I 341.20(b)(1)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (oral) IIIE IIIE 310.545(a)(6)(ii)(B)

Ephedrine (any ingredient) ==== Menstrual/diuretic Menstrual n/a n/a 310.545(a)(24)(ii) ==== Internal analgesic Analgesic n/a n/a 310.545(a)(23)(ii) Ephedrine hydrochloride Cough/cold Cough/cold (bronchodilator) Bronchodilator I I 341.16(b) Miscellaneous external Male genital desensitizer Male genital desensitizer IISE IISE 310.545(a)(10)(iii) Ophthalmic Ophthalmic Vasoconstrictor I I 349.18(a) Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant (oral) IIIE IIIE 310.545(a)(6)(ii)(B)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (topical/inhalant)

I I 341.20(b)(3)

Ephedrine sulfate Cough/cold Cough/cold (bronchodilator) Bronchodilator I I 341.16(c) Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(topical/inhalant) I I 341.20(b)(4)

Hemorrhoidal Anorectal Vasoconstrictor (intrarectal) I I 346.12(a) Hemorrhoidal Anorectal Vasoconstrictor (external) I I 346.10(a) Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant (oral) IIIE IIIE 310.545(a)(6)(ii)(B)

Epinephrine Cough/cold Cough/cold (bronchodilator) Bronchodilator (inhalation) I I 341.16(d) Hemorrhoidal Anorectal Vasoconstrictor (external) IIISE I 346.10(b) Hemorrhoidal Anorectal Vasoconstrictor (intrarectal) IIISE IIISE 346.10(b) Epinephrine bitartrate Cough/cold Cough/cold (bronchodilator) Bronchodilator (inhalation) I I 341.16(e) Epinephrine hydrochloride Hemorrhoidal Anorectal Vasoconstrictor (external) I I 346.10(c) Hemorrhoidal Anorectal Vasoconstrictor (intrarectal) IIE IIE 346.10(c) Epinephrine hydrochloride

(racemic) [see epinephine hydrochloride]

==== ==== ==== ==== ==== ==== Epinephrine undecylenate Hemorrhoidal Anorectal Vasoconstrictor (external) IIISE IIISE 310.545(a)(26)(ix) Hemorrhoidal Anorectal Vasoconstrictor (intrarectal) IIE IIE 310.545(a)(26)(ix) Ergocalciferol Contraceptive/vaginal Vaginal Minor irritations IIIE Withdraw

n/a

Review Panel Report Drug Category ANPR PR FR

dermatitis/psoriasis Dandruff IIIE IIIE 310.545(a)(7)

Ethoxylated alkyl alcohol Miscellaneous external External analgesic Insect bite/sting IISE IISE 310.545(a)(10)(vi) Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(18)(v) Ethyl 4-[bis(hydroxypropyl)]

aminobenzoate Topical analgesic Sunscreen Sunscreen I I 310.545(a)(29) Ethyl alcohol [see alcohol] ==== ==== ==== ==== ==== ==== Ethyl nitrate Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Ethylhexyl p-methoxycinnamate

[see white pine extract, compound]

==== ==== ==== ==== ==== ==== Ethylmorphine hydrochloride Cough/ cold Cough/cold (antitussive) Antitussive IIIE IIIE [52 FR 30054] Eucalyptol Cough/cold Cough/cold (antitussive) Antitussive

(topical/inhalant) IIIE IIIE [52 FR 30055]

Cough/cold Cough/cold (antitussive) Antitussive (mouthwash)

IIIE IIIE [52 FR 30055]

Cough/cold Cough/cold (antitussive) Antitussive (lozenge) IIIE IIIE [52 FR 30054] Cough/cold Cough/cold (expectorant) Expectorant (lozenge) IIIE IIIE 310.545(a)(6)(iii) Cough/cold Cough/cold (expectorant) Expectorant

(topical/inhalant) IIIE IIIE 310.545(a)(6)(iii)

Cough/cold Cough/cold (nasal decongestant) Nasal decongestant (topical/inhalant)

IIIE IIIE 310.545(a)(6)(ii)(A)

Cough/cold Cough/cold (nasal decongestant) Nasal decongestant (mouthwash)

IIIE IIIE 310.545(a)(6)(ii)(A)

Cough/cold Cough/cold (nasal decongestant) Nasal decongestant (lozenge)

IIIE IIIE 310.545(a)(6)(ii)(A)

Cough/cold Cough/cold (nasal decongestant) Nasal decongestant (lozenge)

IIIE IIIE 310.545(a)(6)(ii)(A)

Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a pending Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff IIIE IIIE 310.545(a)(7)

Miscellaneous external External analgesic Diaper rash Defer IISE 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a pending Oral cavity Oral health care Antimicrobial IIIE IIIE pending Oral cavity Oral health care Analgesic/anesthetic IIIE IIIE 310.545(a)(14) Eucalyptol, menthol, methyl

salicylate, and thymol ==== Gingivitis/plaque Antiplaque/gingivitis I ==== pending

Review Panel Report Drug Category ANPR PR FR

Eucalyptus oil ==== External analgesic Fever blister (topical) n/a IIIE 310.545(a)(10)(v) Cough/cold Cough/cold (antitussive) Antitussive (mouthwash) IIIE IIIE [52 FR 30055] Cough/cold Cough/cold (antitussive) Antitussive (lozenge) IIIE IIIE [52 FR 30054] Cough/cold Cough/cold (antitussive) Antitussive (topical/inhalant) IIIE IIIE [52 FR 30055] Cough/cold Cough/cold (expectorant) Expectorant (lozenge) IIIE IIIE 310.545(a)(6)(iii) Cough/cold Cough/cold (expectorant) Expectorant (topical/inhalant) IIIE IIIE 310.545(a)(6)(iii) Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(mouthwash) IIIE IIIE 310.545(a)(6)(ii)(A)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (inhalant room spray)

IIIE IIIE [59 FR 43408]

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (lozenge) IIIE IIIE 310.545(a)(6)(ii)(A)

Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii) Miscellaneous external Hair growth/loss Hair grower IISE n/a 310.527(a) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(18)(vi) Miscellaneous internal Smoking deterrent Smoking deterrent IIE IIE 310.544(d) Topical analgesic External analgesic Counterirritant IIIE IIIE 310.545(a)(10)(ii) Eugenol ==== External analgesic Poison ivy/oak/sumac n/a IIIE 310.545(a)(10)(vii) Dental Relief of oral discomfort Toothache relief I IIISE Pending Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external External analgesic Fever blister (topical) Defer IIIE 310.545(a)(10)(v) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Topical analgesic External analgesic Analgesic/anesthetic IIIE IIIE 310.545(a)(10)(i) Euphorbia pilulifera Cough/cold Cough/cold (bronchodilator) Bronchodilator IIIE IIIE 310.545(a)(6)(iv)(A) Extract white pine compound

[see white pine extract, compound]

==== ==== ==== ==== ==== ==== Fatty acids Miscellaneous external Hair growth/loss Hair grower IISE n/a 310.527(a) Fennel acid Miscellaneous internal Digestive aid Digestive aid (intestinal distress) n/a n/a 310.545(a)(18)(ii) Ferric ammonium citrate Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Ferric chloride Miscellaneous external External analgesic Insect bite/sting IISE IISE 310.545(a)(10)(vi) Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(18)(v)(A) Miscellaneous external Skin protectant Poison ivy/oak/sumac IISE IISE 310.545(a)(18)(vi)(A) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Oral cavity Oral health care Antimicrobial IISE IISE Pending Ferric pyrophosphate Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Ferric subsulfate Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Ferrous furnarate Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Ferrous gluconate Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Ferrous sulfate Miscellaneous internal Menstrual/diuretic Premenstrual/menstrual period n/a IISE 310.545(a)(24)(i) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Flax seed Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Fluid extract ergot [see

ergot, fluidextract] ==== ==== ==== ==== ==== ==== Fluorosalan Antimicrobial I Antimicrobial Antimicrobial IIS IIS Pending

Review Panel Report Drug Category ANPR PR FR

Folic acid Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Formaldehyde solution Dental Relief of oral discomfort Tooth desensitizer IIIE IIIE Pending Formic acid Miscellaneous external Pediculicide Pediculicide n/a n/a 310.545(a)(25)(i) Frangula Laxative Laxative Stimulant laxative IIISE IIISE 310.545(a)(12)(iv)(A) Fructose Miscellaneous internal Overindulgence in

alcohol/food Minimize inebriation IIIE IIIE [48 FR 32873]

Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Galega Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Gamboge Laxative Laxative Stimulant laxative IIS IIS 310.545(a)(12)(iv)(A) Garlic, dehydrated Miscellaneous internal Digestive aid Digestive aid (intestinal distress) IIE IIE 310.545(a)(8)(i) Miscellaneous internal Digestive aid Digestive aid (ippuad) IIE IIE 310.545(a)(8)(i) Gastric mucin Antacid Antacid Antacid IIIE IIIE [39 FR 19873] Gelatin Oral cavity Oral health care Demulcent I I Pending Ophthalmic Ophthalmic Demulcent I I 349.12(c) Gentian violet Miscellaneous internal Anthelmintic Anthelmintic I IIS [51 FR 27758] Oral cavity Oral health care Antimicrobial IIIE IIE Pending Gentiana lutea (gentian) Miscellaneous internal Menstrual/diuretic Premenstrual/menstrual period n/a IISE 310.545(a)(24)(i) Ginger Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Ginger, ground [see ginger, Jamaica] ==== ==== ==== ==== ==== ==== Ginger, Jamaica Miscellaneous internal Smoking deterrent Smoking deterrent IIE IIE 310.544(d) Ginseng Miscellaneous internal Aphrodisiac Aphrodisiac IISE IISE 310.528(a) Sedative Stimulant Stimulant IIE IIE [39 FR 6104] Ginseng, korean Miscellaneous internal Aphrodisiac Aphrodisiac IISE IISE 310.528(a) Glutamic acid Miscellaneous internal Benign prostatic

hypertrophy Benign prostatic hypertrophy IIE IIISE 310.532((a)

Glutamic acid hydrochloride Miscellaneous internal Digestive aid Digestive aid (ippuad) IIE IIE 310.545(a)(8)(i) Miscellaneous internal Digestive aid Digestive aid (intestinal distress) IIE IIE 310.545(a)(8)(i) Miscellaneous internal Stomach acidifier Stomach acidifier IIE IIE 310.540(a) Glycerin Hemorrhoidal Anorectal Antiseptic (intrarectal) IISE IISE 310.545(a)(26)(ii) Hemorrhoidal Anorectal Antiseptic (external) IISE IISE 310.545(a)(26)(ii) Hemorrhoidal Anorectal Protectant (external) I I 346.14(3) Hemorrhoidal Anorectal Protectant (intrarectal) I I 346.14(3) Laxative Laxative Hyperosmotic laxative I I Pending Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer DEF 310.545(a)(10)(iv) Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii) Miscellaneous external Skin protectant Diaper rash Defer IIISE 310.545(a)(18)(iii) Miscellaneous external Skin protectant Fever blister (topical) Defer I Pending Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(18)(vi)(A) Oral cavity Oral health care Demulcent I I Pending Ophthalmic Ophthalmic Demulcent I I 349.12(d)(1) Topical analgesic Otic Ear wax softening agent I IIIE [51 FR 28660] Topical analgesic Skin protectant Skin protectant I I 347.10(h) Glycerin, anhydrous ==== Otic Drying water/water clogged ears n/a IIIE 310.545(a)(15)(ii) ==== Otic Swimmer’s ear prevention n/a IIIE 310.545(a)(15)(ii)

Review Panel Report Drug Category ANPR PR FR

Glycerin, anhydrous [see glycerin]

==== ==== ==== ==== ==== ==== Glyceryl aminobenzoate Topical analgesic Sunscreen Sunscreen I I 310.545(a)(29) Glycine Antacid Antacid Antacid I I 331.11(f) Internal analgesic Internal analgesic Corrective I n/a Pending Laxative Antidiarrheal Antidiarrheal IIE IIE 310.545(a)(3)(i) Laxative Antiemetic Antiemetic IIE IIE [52 FR 15891] Miscellaneous internal Benign prostatic

hypertrophy Benign prostatic hypertrophy IIE IIISE 310.532(a)

Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Glycol salicylate ==== External analgesic Poison ivy/oak/sumac n/a IIIE 310.545(a)(10)(vii) Miscellaneous external External analgesic Fever blister (topical) Defer IIIE 310.545(a)(10)(v) Topical analgesic External analgesic Analgesic/anesthetic IIIE IIIE Pending Glycyrrhiza Miscellaneous internal Aphrodisiac Aphrodisiac IIE IISE 310.528(a) Miscellaneous internal Menstrual/diuretic Premenstrual/menstrual period n/a IISE 310.545(a)(24)(i) Golden seal Miscellaneous internal Aphrodisiac Aphrodisiac IISE IISE 310.528(a) Golden seal [see hydratis] ==== ==== ==== ==== ==== ==== Gotu kola Miscellaneous internal Aphrodisiac Aphrodisiac IISE IISE 310.528(a) Gramicidin Antimicrobial II Antibiotic First aid antibiotic n/a IIISE [52 FR 47322] Antimicrobial II Antibiotic Skin wound protectant IIS Defer [52 FR 47322] Antimicrobial II Antibiotic Skin wound antibiotic IIISE Defer [52 FR 47322] Guaifenesin Cough/cold Cough/cold

(expectorant) Expectorant IIIE IIIE 341.18

Guar gum Laxative Laxative Bulk laxative IIIE IIIE 310.545(a)(12)(i) Miscellaneous internal Weight control Anorectic IIIE IISE 310.545(a)(20) Haloprogin Antimicrobial II Antifungal Anticandidal I n/a n/a Antimicrobial II Antifungal Antifungal I I 333.210(b) Hamamelis water of xi

[see witch hazel] ==== ==== ==== ==== ==== ==== Hard fat ==== Skin protectant Skin protectant n/a n/a 347.10(i) Hemorrhoidal Anorectal Protectant (external) n/a n/a 346.14(4) Hemorrhoidal Anorectal Protectant (intrarectal) n/a n/a 346.14(4) Hectorite Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii) Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(18)(vi)(A) Miscellaneous internal Digestive aid Digestive aid (intestinal distress) n/a n/a 310.545(a)(18)(ii) Hemicellulase Miscellaneous internal Digestive aid Digestive aid (intestinal distress) IIIE IIIE 310.545(a)(8)(i) Miscellaneous internal Exocrine pancreatic

insufficiency Exocrine pancreatic insufficiency IIE IIE 310.543(a)

Hexachlorophene Antimicrobial I Antimicrobial Antimicrobial IIS n/a [37 FR 20163] Contraceptive/vaginal Vaginal Minor irritations IISE Withdraw n/a Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer IISE Pending Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Hexylresorcinol ==== External analgesic Poison ivy/oak/sumac n/a IIIE 310.545(a)(10)(vii) Antimicrobial I Antimicrobial Antimicrobial soap n/a IIE Pending Antimicrobial I Antimicrobial First aid antiseptic n/a I Pending

Review Panel Report Drug Category ANPR PR FR

Antimicrobial I Antimicrobial Health care personnel handwash

IIIE IIIE Pending

Antimicrobial I Antimicrobial Preoperative skin prep IIIE IIIE Pending Antimicrobial I Antimicrobial Skin antiseptic IIIE IIIE Pending Antimicrobial I Antimicrobial Skin wound cleanser I I Pending Antimicrobial I Antimicrobial Skin wound

protectant IIIE IIIE Pending

Antimicrobial I Antimicrobial Surgical hand scrub IIIE IIIE Pending Miscellaneous external External analgesic Fever blister (topical) Defer IIIE 310.545(a)(10)(v) Oral cavity Oral health care Analgesic/anesthetic I I Pending Topical analgesic External analgesic Analgesic/anesthetic IIIE IIIE 310.545(a)(10)(i) Histamine dihydrochloride Miscellaneous external External analgesic Fever blister (topical) Defer IISE 310.545(a)(10)(v) Topical analgesic External analgesic Counterirritant I I Pending Histidine Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Homatropine methylbromide Laxative Antidiarrheal Antidiarrheal IIISE IIISE 310.545(a)(3) Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) IIIE IIIE 310.545(a)(8)(i)

Miscellaneous internal Digestive aid Digestive aid (ippuad) IIE IIE 310.545(a)(8)(i) Miscellaneous internal Menstrual/diuretic Smooth muscle

relaxant IIE IIIE 310.545(a)(24)(i)

Homosalate Miscellaneous external External analgesic Fever blister (topical) Defer Defer Pending Topical analgesic n/a Sunscreen n/a I 352.10(f) Honey Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Horehound Cough/cold Cough/cold

(antitussive) Antitussive IIIE IIIE [52 FR 30054]

Oral cavity Oral health care Expectorant IIIE IIIE 310.545(a)(6)(iii) Hormone constituents Miscellaneous external Hair growth/loss Hair grower IISE IIE 310.527(a) Horsetail Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Huckleberry Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Hyascyamine sulfate Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Hydrangea, powdered extract

(extract of hydrangea) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Hydrastis Hemorrhoidal Anorectal Counterirritant

(intrarectal) IISE IISE 310.545(a)(26)(iv)

Hemorrhoidal Anorectal Antiseptic (external) IISE IISE 310.545(a)(26)(iv) Hemorrhoidal Anorectal Counterirritant

(external) IISE IISE 310.545(a)(26)(iv)

Hemorrhoidal Anorectal Antiseptic (intrarectal)

IISE IISE 310.545(a)(26)(ii)

Miscellaneous internal Aphrodisiac Aphrodisiac IISE IISE 310.528(a) Hydrastis canadensis (golden seal) Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Miscellaneous internal Menstrual/diuretic Menstrual n/a IISE 310.545(a)(24)(i) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Hydrastis fluid extract Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Hydrate magnesium aluminate

activated sulfate Antacid Antacid Antacid n/a n/a 331.11(g)(1) Hydriodic acid syrup Cough/cold Cough/cold

(expectorant) Expectorant IISE IISE 310.545(a)(6)(iii)

Hydrochloric acid Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii)

Review Panel Report Drug Category ANPR PR FR

Hydrochloric acid diluted [see hydrochloric acid, diluted]

==== ==== ==== ==== ==== ==== Hydrochloric acid, diluted Miscellaneous internal Stomach acidifier Stomach acidifier IIE IIE 310.540(a) Hydrocodone bitartrate Cough/cold Cough/cold

(antitussive) Antitussive IIS IIS [52 FR 30054]

Hydrocortisone Antimicrobial II Antifungal Anti-inflammatory I combo n/a n/a Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis/psoriasis IIISE Defer n/a

Topical analgesic External analgesic Antipruritic I I Pending Hydrocortisone (0.25-5%) Miscellaneous external External analgesic Dandruff/seborrheic

dermatitis/psoriasis n/a I Pending

Hydrocortisone (0.5-1%) Miscellaneous external External analgesic Dandruff n/a IIISE Pending Hydrocortisone acetate ==== External analgesic Poison ivy/oak/sumac n/a I Pending Antimicrobial II Antifungal Anti-inflammatory (dissent) I combo n/a n/a Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis/psoriasis IIISE Defer n/a

Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Topical analgesic External analgesic Antipruritic I I Pending Hydrocortisone acetate (0.25-5.0%) Miscellaneous external External analgesic Dandruff/seborrheic

Dermatitis/psoriasis n/a I Pending

Hydrocortisone acetate (0.25-0.5%) Miscellaneous external External analgesic Dandruff/seborrheic

dermatitis /psoriasis n/a I Pending

Hydrocortisone alcohol [see hydrocortisone] ==== ==== ==== ==== ==== ==== Hydrogen fluoride Dental Anticaries Anticavity dental rinse n/a IIISE 310.545(a)(2)(i) Hydrogen peroxide Antimicrobial I Antimicrobial First aid antiseptic n/a I Pending Dental Oral mucosal injury Wound cleanser I I Pending Dental Oral mucosal injury Wound healing agent IIIE IIIE 310.534(a) Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii) Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(18)(vi)(A) Oral cavity Oral health care Antimicrobial IIIE IIIE Pending Oral cavity Oral health care Debriding agent III III Pending Hydrogen peroxide and povidone iodine ==== Gingivitis/plaque Antiplaque/gingivitis n/a IIISE Pending Hydrogen peroxide and sodium bicarbonate ==== Gingivitis/plaque Antiplaque/gingivitis n/a IIISE Pending Hydrogen peroxide, sodium citrate, sodium

lauryl sulfate, and zinc chloride ==== Gingivitis/plaque Antiplaque/gingivitis n/a IIISE Pending Hydroquinone Miscellaneous external Skin bleach Skin bleaching I I Pending Hydroxyethyl cellulose Ophthalmic Ophthalmic Demulcent I I 349.12(a)(2) Hydroxyethylcellulose [see hydroxyethyl

cellulose] ==== ==== ==== ==== ==== ==== Hydroxypropyl methylcellulose

[see hypromellose] ==== ==== ==== ==== ==== ==== Hyoscyamine sulfate Laxative Antidiarrheal Antidiarrheal IIISE IIISE 310.545(a)(3) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Hypromellose Ophthalmic Ophthalmic Demulcent I I 349.12(a)(3)

Review Panel Report Drug Category ANPR PR FR

Ibuprofen Internal analgesic Analgesic n/a I [67 FR 54139] ==== Internal analgesic Antipyretic n/a I [67 FR 54139] ==== Ichthammol Miscellaneous external Boil treatment Boil treatment IISE IIISE 310.531(a) Miscellaneous external Corn/callus remover Corn/callus remover IISE IISE [55 FR 33261] Impatiens biflora tincture Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(18)(vi)(A) Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii) Infusion of rose petal [see rose petal,

infusion of] ==== ==== ==== ==== ==== ==== Inositol Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Iodine Miscellaneous external Wart remover Wart remover IISE IISE [55 FR 33254] Miscellaneous external Corn/callus remover Corn/callus remover IISE IISE [55 FR 33261] Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Oral cavity Oral health care Antimicrobial IIISE IIISE Pending Iodine complex/phosphate ester

of alkylaryloxy polyethylene Antimicrobial I Antimicrobial Surgical hand scrub IIISE IIISE Pending Antimicrobial I Antimicrobial Skin wound cleanser IIISE IIISE Pending Antimicrobial I Antimicrobial Skin wound protectant IIISE IIISE Pending Antimicrobial I Antimicrobial Health care personnel

handwash IIISE IIISE Pending

Antimicrobial I Antimicrobial Preoperative skin preparation IIISE IIISE Pending Antimicrobial I Antimicrobial Antimicrobial soap n/a IISE Pending Antimicrobial I Antimicrobial Skin antiseptic IIISE IIISE Pending Iodine tincture Antimicrobial I Antimicrobial First aid antiseptic n/a I Pending Antimicrobial I Antimicrobial Preoperative skin prep I I Pending Antimicrobial I Antimicrobial Surgical hand scrub IIS IIS Pending Antimicrobial I Antimicrobial Antimicrobial soap n/a IISE Pending Antimicrobial I Antimicrobial Skin wound protectant IISE IIISE Pending Antimicrobial I Antimicrobial Skin wound cleanser IIS IIIS Pending Antimicrobial I Antimicrobial Skin antiseptic IIS IIIS Pending Antimicrobial I Antimicrobial Health care personnel

handwash IISE IISE Pending

Iodine topical solution Antimicrobial I Antimicrobial First aid antiseptic n/a I Pending Iodized lime Cough/cold Cough/cold

(expectorant) Expectorant IISE IISE 310.545(a)(6)(iii)

Iodoantipyrine Internal analgesic Internal analgesic Analgesic IISE IISE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antipyretic IISE IISE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antirheumatic IISE Not OTC 310.545(a)(23)(i) Iodochlorhydroxyquin [see clioquinol] ==== ==== ==== ==== ==== ==== Ipecac Cough/cold Cough/cold

(expectorant) Expectorant IIE IIE 310.545(a)(6)(iii)

Ipecac fluidextract Cough/cold Cough/cold

(expectorant) Expectorant IIE IIE 310.545(a)(6)(iii)

Miscellaneous internal Poison treatment Emetic n/a IIS 310.545(a)(16) Ipecac syrup Cough/cold Cough/cold

(expectorant) Expectorant IIIE IIIE 310.545(a)(6)(iii)

Miscellaneous internal Emetic Emetic I I Pending Miscellaneous internal Poison treatment Emetic n/a I Pending Ipecac tincture Miscellaneous internal Poison treatment Emetic n/a IIS 310.545(a)(16) Ipomea Laxative Laxative Stimulant laxative IIS IIS 310.545(a)(12)(iv)(A)

Review Panel Report Drug Category ANPR PR FR

Iron ox bile Miscellaneous internal Digestive aid Digestive aid (intestinal distress) n/a n/a 310.545(a)(18)(ii) Iron oxide Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(18)(vi)(A) Isobornyl thiocyanoacetate Miscellaneous external Pediculicide Pediculicide IISE IISE 310.545(a)(25)(i) Isobutamben Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Isobutyl p-aminobenzoate

[see isobutaben] ==== ==== ==== ==== ==== ==== Isoleucine Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Isopropyl alcohol Miscellaneous external Alcohols (topical) Antiseptic I I Pending Miscellaneous external Mercury First aid antiseptic n/a I Pending Miscellaneous external Analgesic Astringent IISE n/a Pending Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(18)(vi)(A) Isopropyl palmitate ==== Insect bite/sting Insect bite/sting n/a n/a 310.545(a)(18)(v)(B) ==== Poison ivy/oak/sumac Poison ivy/oak/sumac n/a n/a 310.545(a)(18)(vi)(B) ==== Skin protectant Skin protectant n/a n/a 310.545(a)(18)(i)(B) Jalap Laxative Laxative Stimulant laxative IIS IIS 310.545(a)(12)(iv)(A) John’s wort Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Jojoba oil Miscellaneous external Hair growth/loss Hair grower n/a IIE 310.527(a) Juniper Miscellaneous internal Digestive aid Digestive aid (intestinal distress) n/a n/a 310.545(a)(18)(ii) Juniper oil (oil of juniper) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Juniper tar ==== Antifungal Diaper rash n/a n/a 310.545(a)(22)(i) ==== Antimicrobial Diaper rash n/a n/a Pending ==== External analgesic Diaper rash n/a IISE 310.545(a)(10)(iv) ==== External analgesic Fever blister (topical) n/a I Pending ==== External analgesic Poison ivy/oak/sumac n/a I Pending ==== Skin protectant Diaper rash n/a n/a Pending Hemorrhoidal Anorectal Counterirritant (external) IIISE n/a n/a Hemorrhoidal Anorectal Analgesic (external) n/a I 346.16(b) Hemorrhoidal Anorectal Counterirritant (intrarectal) IIISE n/a n/a Miscellaneous external Boil treatment Boil treatment IISE IIISE 310.531(a) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis/psoriasis IIIE IIIE 310.545(a)(7)

Topical analgesic External analgesic Analgesic/anesthetic I I Pending Juniper, extract Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Kaolin ==== Skin protectant Poison ivy/oak/sumac n/a I 347.10(j) Antacid Antacid Antacid IIIE IIIE [39 FR 19873] Hemorrhoidal Anorectal Protectant (intrarectal) I I 346.14(5) Hemorrhoidal Anorectal Protectant (external) I I 346.14(5) Laxative Antidiarrheal Antidiarrheal IIIE IIIE 347.10(b) Miscellaneous external Skin protectant Diaper rash n/a I Pending Topical analgesic Skin protectant Skin protectant I I 347.10(j) Kaolin, colloidal Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Karaya [see karaya gum] ==== ==== ==== ==== ==== ====

Review Panel Report Drug Category ANPR PR FR

Karaya gum Laxative Laxative Bulk laxative I I Pending Miscellaneous internal Weight control Anorectic IIIE IISE 310.545(a)(20) Kelp Miscellaneous internal Weight control Anorectic IIIE IISE 310.545(a)(20) Knotgrass Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Lactic acid Contraceptive/vaginal Vaginal Lowers surface

tension mucolytic effects

IIIE Withdraw n/a

Contraceptive/vaginal Vaginal Alters vaginal pH IIIE Withdraw n/a Miscellaneous external Wart remover Wart remover IIIE IIIE [55 FR 33254] Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Lactobacillus acidophilus Laxative Antidiarrheal Antidiarrheal IIIE IIIE 310.545(a)(3)(i) Miscellaneous internal Fever blister (oral) Fever blister/oral IIIE IIIE 310.537(a) Lactobacillus bulgaricus Laxative Antidiarrheal Antidiarrheal IIIE IIIE 310.545(a)(3)(i) Miscellaneous internal Fever blister (oral) Fever blister/oral IIIE IIIE 310.537(a) Lactose Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Lanolin ==== Skin protectant Skin protectant n/a n/a 347.10(k) Hemorrhoidal Anorectal Protectant (external) I I 346.14(6) Hemorrhoidal Anorectal Protectant

(intrarectal) I I 346.14(6)

sumac Defer IISE 310.545(a)(10)(vii)

Miscellaneous external Hair growth/loss Hair grower IIE IIE 310.527(a) Miscellaneous external Skin protectant Diaper rash Defer I Pending Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer IISE 310.545(a)(18)(vi)

Lanolin (in combination) Ophthalmic Ophthalmic Emollient I I 349.14(a)(2) Lanolin alcohol [see lanolin alcohols] ==== ==== ==== ==== ==== ==== Lanolin alcohols Hemorrhoidal Anorectal Protectant (external) I IIISE 310.545(a)(26)(viii) Hemorrhoidal Anorectal Protectant

(intrarectal) I IIISE 310.545(a)(26)(viii)

Miscellaneous external External analgesic Fever blister (topical) Defer n/a Pending Miscellaneous external Skin protectant Fever blister (topical) Defer n/a Pending Lanolin anhydrous [see lanolin, anhydrous] ==== ==== ==== ==== ==== ==== Lanolin nonionic derivatives Ophthalmic Ophthalmic Emollient I I 349.14 Lanolin, anhydrous (in combination) Ophthalmic Ophthalmic Emollient I I 349.14(a)(1) lappa extract Hemorrhoidal Anorectal Anorectal (external) IISE IISE 310.545(a)(26)(vii) Hemorrhoidal Anorectal Anorectal (intrarectal) IISE IISE 310.545(a)(26)(vii) Laureth 10s Contraceptive/vaginal Contraceptive (vaginal) Contraceptive IIIE Withdraw) 310.545(a)(28 Lauric diethanolamide Miscellaneous external Hair growth/loss Hair grower IISE n/a 310.527(a) Lauryl isoquinolinium bromide Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff IIIE IIIE 310.545(a)(7)

Review Panel Report Drug Category ANPR PR FR

Lavender compound, tincture of Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Lavender oil Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Lawsone with dihydroxyacetone Topical analgesic Sunscreen Sunscreen I I 310.545(a)(29) L-Desoxyephedrine [see desoxyephedrine, L-] ==== ==== ==== ==== ==== ==== Lead acetate Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IISE 310.545(a)(10)(vii)

Miscellaneous external Skin protectant Poison ivy/oak/ sumac

Defer IISE 310.545(a)(18)(vi)(A)

Lecithin Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Lemon oil (terpeneless) Miscellaneous internal Smoking deterrent Smoking deterrent IIE IIE 310.544(d) Leptandra extract Hemorrhoidal Anorectal Anorectal (external) IISE IISE 310.545(a)(26)(vii) Hemorrhoidal Anorectal Anorectal (intrarectal) IISE IISE 310.545(a)(26)(vii) Leucine Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Levmetamfetamine Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(topical/inhalant)) IIIE I 341.20(b)(1)

Levomethamphetamine [see desoxyephedrine, L-]

==== ==== ==== ==== ==== ==== Licorice Miscellaneous internal Aphrodisiac Aphrodisiac IISE IISE 310.528(a) Licorice root extract Miscellaneous internal Smoking deterrent Smoking deterrent IIE IIE 310.544(d) Lidocaine Hemorrhoidal Anorectal Anesthetic (external) IIIE I 346.10(f) Hemorrhoidal Anorectal Anesthetic

(intrarectal) IIIE IIIE [55 FR 1779]

Miscellaneous external External analgesic Fever blister (topical) Defer I Pending Miscellaneous external Male genital

desensitizer Male genital

desensitizer I I 348.10(a)(2)

Miscellaneous external External analgesic Poison ivy/oak/ sumac

Defer I Pending

Miscellaneous external Skin protectant Poison ivy/oak/ sumac

Defer IISE 310.545(a)(18)(vi)(A)

Oral cavity Oral health care Analgesic/anesthetic IIS IIS 310.545(a)(14) Topical analgesic External analgesic Analgesic/anesthetic I I Pending Lidocaine hydrochloride ==== External analgesic Poison ivy/oak/

sumac n/a I Pending

Miscellaneous external External analgesic Fever blister (topical) Defer I Pending Oral cavity Oral health care Analgesic/anesthetic IIS IIS 310.545(a)(14) Topical analgesic External analgesic Analgesic/anesthetic I I Pending Linden Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Lipase Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Live yeast cell derivative ==== Insect bite/sting Insect bite/sting n/a n/a 310.545(a)(18)(v)(B) ==== Poison ivy/oak/sumac Poison ivy/oak/

sumac n/a n/a 310.545(a)(18)(vi)(B)

Topical analgesic Skin protectant Skin protectant IIIE IIIE 310.545(a)(18)(i)(B) Liver concentrate Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Lobeline Miscellaneous internal Smoking deterrent Smoking deterrent IIIE IIIE 310.544(d)

Review Panel Report Drug Category ANPR PR FR

Lysine Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Lysine aspirin Internal analgesic Internal analgesic Analgesic n/a IISE 310.545(a)(23)(i) Lysine hydrochloride Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Miscellaneous internal Fever blister (oral) Fever blister/oral IIIE IIIE 310.537(a) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Magaldrate Antacid Antacid Antacid I I 331.11(g)(2) Magnesium Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Magnesium aluminum silicate Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Antacid Antacid Antacid I I 331.11(g)(3)

331.11(k)(2)(1) Magnesium aluminumsilicate

[see magnesium aluminum silicate] ==== ==== ==== ==== ==== ==== Magnesium carbonate Antacid Antacid Antacid I I 331.11(g)(4) Internal analgesic Internal analgesic Corrective I n/a n/a Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous internal Overindulgence in

alcohol/food Overindulgence

remedies (hangover)

I I Pending

Magnesium citrate Laxative Laxative Saline laxative

(oral solution) I I Pending

Magnesium glycinate Antacid Antacid Antacid I I 331.11(g)(5) Magnesium hydroxide Antacid Antacid Antacid I I 331.11(g)(6) Internal analgesic Internal analgesic Corrective I n/a Pending Laxative Laxative Saline laxative I I Pending Miscellaneous internal Digestive aid Digestive aid (ippuad) IIIE IIIE 310.545(a)(8)(i) Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) IIIE IIIE 310.545(a)(8)(i)

Magnesium oxide Antacid Antacid Antacid I I 331.11(g)(7) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Magnesium salicylate Internal analgesic Internal analgesic Analgesic I I Pending Internal analgesic Internal analgesic Antipyretic I I Pending Internal analgesic Internal analgesic Antirheumatic I Not OTC n/a Miscellaneous internal Menstrual/diuretic Analgesic I I Pending Magnesium sulfate Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Laxative Laxative Saline laxative I I Pending Miscellaneous external Boil treatment Boil treatment IISE IIISE 310.531(a) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Magnesium trisilicate Antacid Antacid Antacid I I 331.11(g)(8) 331

11(k)(3)(1) Miscellaneous internal Digestive aid Digestive aid (ippuad) IIIE IIIE 310.545(a)(8)(i) Miscellaneous internal Overindulgence in

alcohol/food Overindulgence

remedies (hangover)

I I Pending

Malt Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Malt soup extract Laxative Laxative Bulk laxative I I Pending Maltodextrin Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20)

Review Panel Report Drug Category ANPR PR FR

Mandrake Miscellaneous internal Aphrodisiac Aphrodisiac n/a n/a 310.528(a) Manganese citrate Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Mannitol Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Meclizine hydrochloride Laxative Antiemetic Antiemetic I I 336.10(d) Menfegol Contraceptive/vaginal Contraceptive (vaginal) Contraceptive

(dissent) I Withdraw n/a

Menthol Antimicrobial II Antifungal Antifungal IIE IIE 310.545(a)(22)(ii) Cough/cold Cough/cold

(antitussive) Antitussive

(mouthwash) IIIE IIIE [52 FR 30055]

Cough/cold Cough/cold (antitussive)

Antitussive (topical/inhalant)

IIIE I 341.14(b)(2)

Cough/cold Cough/cold (antitussive)

Antitussive (lozenge) IIIE I 341.14(b)(2)

Cough/cold Cough/cold (expectorant)

Expectorant (topical/inhalant)

IIIE IIIE 310.545(a)(6)(iii)

Cough/cold Cough/cold (expectorant)

Expectorant (lozenge) IIIE IIIE 310.545(a)(6)(iii)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (lozenge)

IIIE IIIE [59 FR 43408]

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (mouthwash)

IIIE IIIE 310.545(a)(6)(ii)(A)

Dental Relief of oral discomfort Toothache relief IIS IIS Pending Hemorrhoidal Anorectal Analgesic (external) n/a I 346.16(c) Miscellaneous external Antifungal Diaper rash Defer IISE 310.545(a)(22)(ii) Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis/ psoriasis

IIIE IIIE 310.545(a)(7)

Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external External analgesic Diaper rash Defer IISE 310.545(a)(10)(iv) Miscellaneous external External analgesic Insect bite/sting IISE I Pending Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer I Pending

Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Skin protectant Fever blister (topical) Defer Defer Pending Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(18)(v)(A) Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer IISE 310.545(a)(18)(vi)(A)

Miscellaneous external Wart remover Wart remover IISE IISE [55 FR 33254] Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous internal Smoking deterrent Smoking deterrent IIE IIE 310.544(d) Oral cavity Oral health care Antimicrobial IIIE IIIE Pending Oral cavity Oral health care Analgesic/anesthetic I I Pending Topical analgesic External analgesic Counterirritant I I Pending Topical analgesic External analgesic Analgesic/anesthetic I I Pending Menthol (0.1-1.0%) Miscellaneous external External analgesic Fever blister (topical) Defer I Pending Menthol (1.25-16%) Miscellaneous external External analgesic Fever blister (topical) Defer IIIE 310.545(a)(10)(v) Hemorrhoidal Anorectal Counterirritant

(intrarectal) IIE IIE 310.545(a)(26)(iv)

Hemorrhoidal Anorectal Counterirritant (external)

I IIE 310.545(a)(26)(iv)

Menthyl anthranilate [see meradimate] ==== ==== ==== ==== ==== ==== Meradimate Topical analgesic Sunscreen Sunscreen I I 352.10(h) Meralein sodium Oral cavity Oral health care Antimicrobial IISE IISE Pending

Review Panel Report Drug Category ANPR PR FR

Merbromin Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IISE 310.545(a)(10)(vii)

Miscellaneous external Skin protectant Poison ivy/oak/ sumac

Defer IISE 310.545(a)(18)(vi)

Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Merbromin (mercurochrome) Miscellaneous external Mercury First aid antiseptic n/a IIIE 310.545(a)(27)(i) Mercufenol chloride Miscellaneous external Mercury First aid antiseptic n/a IIIE 310.545(a)(27)(i) Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Miscellaneous external Antimicrobial First aid antiseptic n/a IIS 310.545(a)(27)(i) Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IISE 310.545(a)(10)(vii)

Miscellaneous external Skin protectant Poison ivy/oak/ sumac

Defer IISE 310.545(a)(18)(vi)(A)

Mercuric chloride [see calomel] ==== ==== ==== ==== ==== ==== Mercuric oxide, yellow Miscellaneous external Mercury First aid antiseptic n/a IISE 310.545(a)(27)(i) Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Ophthalmic Ophthalmic Anti-infective IIISE IISE 310.545(a)(21)(ii) Mercuric salicylate Miscellaneous external Mercury First aid antiseptic n/a IISE 310.545(a)(27)(i) Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Mercuric sulfide, red Miscellaneous external Mercury First aid antiseptic n/a IISE 310.545(a)(27)(i) Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Mercurous chloride [see calomel] ==== ==== ==== ==== ==== ==== Mercury Miscellaneous external Mercury First aid antiseptic n/a IISE 310.545(a)(27)(i) Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Mercury (any ingredient) ==== Antimicrobial Diaper rash Defer n/a 310.545(a)(27)(ii) ==== Contraceptive (vaginal) Contraceptive n/a n/a 310.545(a)(28) Mercury chloride [see mercuric chloride] ==== ==== ==== ==== ==== ==== Mercury oleate Miscellaneous external Mercury First aid antiseptic n/a IISE 310.545(a)(27)(i) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Psoriasis IIE IIE 310.545(a)(7)

Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Mercury, ammoniated Miscellaneous external Antimicrobial First aid antiseptic n/a IISE 310.545(a)(27)(i) Miscellaneous external Skin bleach Skin bleaching IISE IISE 310.545(a)(17) Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Metaproterenol sulfate Cough/cold Cough/cold

(bronchodilator) Bronchodilator n/a III 310.545(a)(6)(iv)(A)

Methapyrilene Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Methapyrilene fumarate Cough/cold Cough/cold

(antihistamine) Antihistamine I IIS 310.545(a)(6)(i)(A)&(B)

Internal analgesic Internal analgesic Analgesic adjuvant IIIE IIS 310.545(a)(23)(i) Internal analgesic Internal analgesic Antihistamine IIE n/a 310.545(a)(6)(A) Internal analgesic Internal analgesic Antipyretic adjuvant IIIE IIS 310.545(a)(23)(i) Internal analgesic Internal analgesic Antirheumatic

adjuvant IIIE IIS 310.545(a)(23)(i)

Sedative Daytime sedative Sedative IIISE IISE 310.519(a) Sedative Nighttime sleep aid Sleep aid IIISE IIS [54 FR 6826]

Review Panel Report Drug Category ANPR PR FR

Methapyrilene hydrochloride ==== External analgesic Poison ivy/oak/

sumac n/a IISE 310.545(a)(10)(vii)

Cough/cold Cough/cold (antihistamine)

Antihistamine I IIS 310.545(a)(6)(i)(A)&(B)

Miscellaneous external External analgesic Fever blister (topical) Defer IIE 310.545(a)(10)(v) Miscellaneous internal Menstrual/diuretic Menstrual n/a IISE 310.545(a)(24)(i) Sedative Nighttime sleep aid Sleep aid IIISE IIS [54 FR 6826] Sedative Daytime sedative Sedative IIISE IIS 310.519(a) Topical analgesic External analgesic Analgesic/anesthetic I IIS 310.545(a)(10)(i) Methenamine Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Methionine Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Methoxyphenamine hydrochloride Cough/cold Cough/cold

(bronchodilator) Bronchodilator I IIE 310.545(a)(6)(iv)(A)

Methoxypolyoxyethylene glycol 550 laurate Contraceptive/vaginal Contraceptive (vaginal) Contraceptive IIIE IIIE 310.545(a)(28) Methyl nicotinate Miscellaneous external External analgesic Fever blister (topical) Defer IIIE 310.545(a)(10)(v) Topical analgesic External analgesic Counterirritant I I Pending Methyl salicylate Dental Relief of oral discomfort Toothache relief IISE IISE Pending Dental Relief of oral discomfort Oral mucosal

analgesic IISE IISE Pending

Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff IIIE IIIE 310.545(a)(7)

Miscellaneous external External analgesic Astringent n/a n/a Pending Miscellaneous external External analgesic Fever blister (topical) Defer IIIE 310.545(a)(10)(v) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Corn/callus remover Corn/callus remover IISE IISE [55 FR 33261] Miscellaneous internal Smoking deterrent Smoking deterrent IIE IIE 310.544(d) Oral cavity Oral health care Antimicrobial IIIE IIIE Pending Oral cavity Oral health care Analgesic/anesthetic IIIE IIIE 310.545(a)(14) Topical analgesic External analgesic Counterirritant I I Pending Methylbenzethonium chloride Antimicrobial I Antimicrobial First aid antiseptic n/a I Pending Antimicrobial I Antimicrobial Antimicrobial soap n/a IISE Pending Antimicrobial I Antimicrobial Skin antiseptic IIISE IIISE Pending Antimicrobial I Antimicrobial Skin protectant IIISE IIISE Pending Antimicrobial I Antimicrobial Preoperative skin prep IIISE IIISE Pending Antimicrobial I Antimicrobial Skin wound cleanser I I Pending Antimicrobial I Antimicrobial Surgical hand scrub IIISE IIISE Pending Antimicrobial I Antimicrobial Health care personnel

handwash IIIE IIIE Pending

Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer IIISE Pending Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Cradle cap IIIE IIIE 310.545(a)(7)

Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Corn/callus remover Corn/callus remover IISE IISE [55 FR 33261] Methylcellulose Antacid Antacid Antacid IIIE IIIE [39 FR 19873] Laxative Laxative Bulk laxative I I Pending Miscellaneous internal Weight control Anorectic IIIE IISE 310.545(a)(20) Ophthalmic Ophthalmic Demulcent I I 349.12(a)(4) Methylene blue Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i)

Review Panel Report Drug Category ANPR PR FR

Methylparaben Antimicrobial II Antifungal Antifungal IIISE IIISE 310.545(a)(22)(ii) Methyltestosterone Miscellaneous internal Aphrodisiac Aphrodisiac IIS IIS 310.528(a) Miconazole nitrate Antimicrobial II Antifungal Anticandidal I n/a n/a Antimicrobial II Antifungal Antifungal I I 333.210(c) Microporous cellulose

[see cellulose, microporous] ==== ==== ==== ==== ==== ==== Milk solids, dried Antacid Antacid Antacid I I 331.11(h) Mineral oil Hemorrhoidal Anorectal Protectant (external) I I 346.14(7) Hemorrhoidal Anorectal Protectant

(intrarectal) I I 346.14(7)

Laxative Laxative Lubricant laxative I I Pending Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Diaper rash Defer I Pending Miscellaneous external Skin protectant Fever blister (topical) Defer n/a Pending Ophthalmic Ophthalmic Emollient I I 349.14(b)(2) Mineral oil, emulsified [see mineral oil] ==== ==== ==== ==== ==== ==== Mineral oil, light Ophthalmic Ophthalmic Emollient I I 349.14(b)(1) Minerals Miscellaneous internal Aphrodisiac Aphrodisiac n/a IISE 310.528(a) Mono-and di-glycerides Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Mullein Hemorrhoidal Anorectal Anorectal (external) IISE IISE 310.545(a)(26)(vii) Hemorrhoidal Anorectal Anorectal (intrarectal) IISE IISE 310.545(a)(26)(vii) Mustard oil [see allyl isothiocyanate] ==== ==== ==== ==== ==== ==== Mycozyme Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Myrrh Dental Relief of oral discomfort Oral mucosal

protectant IIISE IIISE Pending

Myrrh tincture Oral cavity Oral health care Antimicrobial IISE IISE 310.545(a)(14) Oral cavity Oral health care Astringent IISE IISE Pending Myrrh tincture of [see myrrh tincture] ==== ==== ==== ==== ==== ==== Myrrh, fluid extract of Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Naphazoline hydrochloride Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(topical/inhalant)) I I 341.20(b)(6)

Ophthalmic Ophthalmic Vasoconstrictor I I 349.18(b) Natural estrogenic hormone Miscellaneous internal Menstrual/diuretic Menstrual n/a IISE 310.545(a)(24)(i) Neomycin sulfate Antimicrobial II Antibiotic Skin wound

protectant IIIS Defer n/a

Neomycin sulfate (cream) Antimicrobial II Antibiotic First aid antibiotic n/a I 333.110(e) Neomycin sulfate (ointment) Antimicrobial II Antibiotic First aid antibiotic n/a I 333.110(d) Nettle Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii)

Review Panel Report Drug Category ANPR PR FR

Niacinamide Miscellaneous internal Menstrual/diuretic Menstrual n/a IISE 310.545(a)(24)(i) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Sedative Daytime sedative Sedative IIE IISE 310.519(a) Nickel-pectin Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Nitromersol Miscellaneous external Mercury First aid antiseptic n/a IISE 310.545(a)(27)(i) Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Oral cavity Oral health care Antimicrobial IISE IISE Pending Nonoxynol 9 Contraceptive/vaginal Vaginal Lowers surface

tension mucolytic effects

I Withdraw n/a

Contraceptive/vaginal Vaginal Minor irritations IIIE Withdraw n/a Contraceptive/vaginal Contraceptive (vaginal) Contraceptive I Withdraw n/a Nonylphenoxypoly (ethyleneoxy) ethanol iodine Antimicrobial I Antimicrobial Surgical hand scrub IIISE IIISE Pending Antimicrobial I Antimicrobial Antimicrobial soap n/a IISE Pending Antimicrobial I Antimicrobial Health care personnel

handwash IIISE IIISE Pending

Antimicrobial I Antimicrobial Skin wound cleanser IIISE IIISE Pending Antimicrobial I Antimicrobial Preoperative skin prep IIISE IIISE Pending Antimicrobial I Antimicrobial Skin antiseptic IIISE IIISE Pending Noscapine Cough/cold Cough/cold

(antitussive) Antitussive IIIE IIIE [52 FR 30054]

Noscapine hydrochloride Cough/cold Cough/cold

(antitussive) Antitussive IIIE IIIE [52 FR 30054]

Nucleic acids Miscellaneous external Hair growth/loss Hair grower n/a n/a 310.527(a) Nutmeg oil (oil of nutmeg) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Nux vomica Miscellaneous internal Aphrodisiac Aphrodisiac IISE IISE 310.528(a) Nux vomica extract Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Nystatin Antimicrobial II Antifungal Anticandidia I IIISE 310.545(a)(22)(iv) Obtundia surgical dressing Miscellaneous external External analgesic Insect bite/sting IISE IISE Pending Miscellaneous external Skin protectant Insect bite/sting IISE IISE Pending Octinoxate Topical analgesic Sunscreen Sunscreen I I 352.10(j) Octisalate Topical analgesic Sunscreen Sunscreen I I 352.10(k) Octocrylene Topical analgesic Sunscreen Sunscreen I I 352.10(i) Octoxynol 9 Contraceptive/vaginal Vaginal Minor irritations IIIE Withdraw 310.545(a)(28)(ii) Contraceptive/vaginal Vaginal Lowers surface

tension mucolytic effects

I Withdraw 310.545(a)(28)(ii)

Contraceptive/vaginal Contraceptive (vaginal) Contraceptive I Withdraw 310.545(a)(28)(ii) Octyl salicylate [see octisalate] ==== ==== ==== ==== ==== ==== Octyldodecanol Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Fever blister (topical) Defer n/a Pending Octylmethoxycinnamate [see octinoxate] ==== ==== ==== ==== ==== ==== Octyl Triazone n/a TEA Sunscreen n/a

Review Panel Report Drug Category ANPR PR FR

Oil of erigeron Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Olive oil Miscellaneous external Hair growth/loss Hair grower IISE n/a 310.527(a) Opium powder [see opium, powdered] ==== ==== ==== ==== ==== ==== Opium tincture Laxative Antidiarrheal Antidiarrheal I IIISE 310.545(a)(3)(i) Opium, tincture of [see opium tincture] ==== ==== ==== ==== ==== ==== Opium, powdered Laxative Antidiarrheal Antidiarrheal I IIISE 310.545(a)(3)(i) Organic vegetables Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Orthophosphoric acid Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Orthophosphoric acid [see phosphoric acid] ==== ==== ==== ==== ==== ==== Ox bile Laxative Laxative Stimulant laxative IIISE IIISE 310.545(a)(12)(iv)(A) Ox bile extract Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) IIE IIE 310.545(a)(8)(i))

Miscellaneous internal Digestive aid Digestive aid (ippuad) IIE IIE 310.545(a)(8)(i) Oxybenzone Topical analgecis Sunscreen Sunscreen I I 352.10(1) Oxymetazoline hydrochloride Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(topical/inhalant) I I 341.20(b)(7)

Oxyquinoline Antimicrobial II Antifungal Antifungal IIISE IIISE 310.545(a)(22)(ii) Miscellaneous external Antifungal Diaper rash Defer IISE 310.545(a)(22)(ii) Miscellaneous external Antimicrobial Diaper rash Defer IIISE Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Oral cavity Oral health care Antimicrobial IIISE IIISE Pending Oxyquinoline citrate Contraceptive/vaginal Vaginal Minor irritations IIISE Withdraw n/a Oxyquinoline sulfate Antimicrobial II Antifungal Antifungal IIISE IIISE 310.545(a)(22)(ii) Contraceptive/vaginal Vaginal Minor irritations IIISE Withdraw n/a Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Miscellaneous external External analgesic Astringent IISE n/a n/a Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Oxyquinoline sulfate [see oxyquinoline] ==== ==== ==== ==== ==== ==== Oxytetracycline hydrochloride Antimicrobial II Antibiotic First aid antibiotic n/a I 333.120 [combos] Antimicrobial II Antibiotic Skin wound antibiotic IIIE Defer n/a Antimicrobial II Antibiotic Skin wound

protectant I Defer n/a

Ozokerite Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Paba [see aminobenzoic acid] ==== ==== ==== ==== ==== ==== Padimate A Miscellaneous external External analgesic Fever blister (topical) Defer Defer Pending Miscellaneous external Skin protectant Fever blister (topical) Defer Defer Pending Topical analgesic Sunscreen Sunscreen (≥5%) I IISE Pending Topical analgesic Sunscreen Sunscreen (<5%) I IIISE Pending Padimate O Topical analgesic Sunscreen Sunscreen I I 352.10(m) Pamabrom Miscellaneous internal Menstrual/diuretic Diuretic I I Pending

Review Panel Report Drug Category ANPR PR FR

Pancreatin Miscellaneous internal Digestive aid Digestive aid (ippuad) IIE IIE 310.545(a)(8)(i) Miscellaneous internal Digestive aid Digestive aid (intestinal

distress) IIIE IIIE 310.545(a)(8)(i)

Miscellaneous internal Exocrine pancreatic insufficiency

Exocrine pancreatic insufficiency

I I 310.543(a)

Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Pancrelipase Miscellaneous internal Digestive aid Digestive aid (intestinal

distress) IIIE IIIE 310.545(a)(8)(i)

Miscellaneous internal Digestive aid Digestive aid (ippuad) IIE IIE 310.545(a)(8)(i) Miscellaneous internal Exocrine pancreatic

insufficiency Exocrine pancreatic

insufficiency I I 310.543(a)

Panthenol Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external External analgesic Insect bite/sting n/a IIIE 310.545(a)(10)(vi) Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IIIE 310.545(a)(10)(vii)

Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(18)(vi) Miscellaneous external Corn/callus remover Corn/callus remover IISE IISE [55 FR 33261] Pantothenic acid Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Papain Contraceptive/vaginal Vaginal Lowers surface tension

mucolytic effects IIIE n/a Withdraw

Miscellaneous internal Digestive aid Digestive aid (intestinal distress)

IIE IIE 310.545(a)(8)(i)

Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Papaya enzymes Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Papaya, natural Miscellaneous internal Digestive aid Digestive aid (intestinal

distress) n/a n/a 310.545(a)(18)(ii)

Para-chloromercuriphenol Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer IISE 310.545(a)(27)(ii) Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Mercury First aid antiseptic IISE n/a 310.545(a)(27)(i) Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Miscellaneous external Skin protectant Diaper rash Defer n/a 310.545(a)(27)(ii) Para-t-butyl-m-cresol Miscellaneous external External analgesic Astringent IISE n/a n/a Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Para-tertiary-butyl-meta-cresol

[see para-t-butyl-m-cresol] ==== ==== ==== ==== ==== ==== Paraffin Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Ophthalmic Ophthalmic Emollient I I 349.14(b)(3) Para-t-butyl-m-cresol Miscellaneous external External analgesic Astringent IISE n/a n/a Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Para-tertiary-butyl-meta-cresol [see

p-t-butyl-m-cresol] ==== ==== ==== ==== ==== ==== Paregoric Laxative Antidiarrheal Antidiarrheal I IIISE 310.545(a)(3)(i) Parethoxycaine hydrochloride Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IISE 310.545(a)(10)(vii) Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(18)(vi)(A) Parsley Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i)

Review Panel Report Drug Category ANPR PR FR

Passion flower extract Sedative Nighttime sleep aid Sleep aid IIE IIE [54 FR 6826] Pectin Laxative Antidiarrheal Antidiarrheal IIIE IIIE 310.545(a)(3)(ii) Miscellaneous external External analgesic Fever blister (topical) Defer IIISE 310.545(a)(10)(v) Miscellaneous external Skin protectant Fever blister (topical) Defer Defer Pending Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Oral cavity Oral health care Demulcent I I Pending Pega palo Miscellaneous internal Aphrodisiac Aphrodisiac IISE IISE 310.528(a) Peppermint Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Peppermint oil Cough/cold Cough/cold

(antitussive) Antitussive

(topical/inhalant) IIIE IIIE [52 FR 30054]

Cough/cold Cough/cold (expectorant)

Expectorant (lozenge) IIIE IIIE 310.545(a)(6)(iii)

Cough/cold Cough/cold (expectorant)

Expectorant (topical/inhalant)

IIIE IIIE 310.545(a)(6)(iii)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (inhalant room spray)

IIIE IIIE [59 FR 43408]

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (lozenge)

IIIE IIIE [59 FR 43408]

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (mouthwash)

IIIE IIIE 310.545(a)(6)(ii)(A)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (topical/inhalant)

IIIE IIIE [59 FR 43408]

Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Astringent IISE n/a n/a Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external External analgesic Insect bite/sting IISE IISE 310.545(a)(10)(vi) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(18)(v) Miscellaneous internal Digestive aid Digestive aid (ippuad) IIIE IIIE 310.545(a)(8)(i) Peppermint oil and sage oil ==== Gingivitis/plaque Antiplaque/gingivitis n/a IIIE Pending Peppermint spirit Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Miscellaneous internal Menstrual/diuretic Premenstrual/menstrual

period n/a IISE 310.545(a)(24)(i)

Pepsin Miscellaneous internal Digestive aid Digestive aid (ippuad) IIE IIE 310.545(a)(8)(i) Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) IIE IIE 310.545(a)(8)(i)

Miscellaneous internal Stomach acidifier Stomach acidifier IIE IIE 310.540(a) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Pepsin, essence Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Peruvian balsam Hemorrhoidal Anorectal Wound healing agent

(intrarectal) IIIE IIIE 310.545(a)(26)(x)

Hemorrhoidal Anorectal Wound healing (external)

IIIE IIIE 310.545(a)(26)(x)

Review Panel Report Drug Category ANPR PR FR

Petrolatum Hemorrhoidal Anorectal Protectant (external) n/a I 346.14(8) Hemorrhoidal Anorectal Protectant

(intrarectal) n/a I 346.14(8)

(intrarectal) I I 346.14(10)

Hemorrhoidal Anorectal Protectant (external) I I 346.14(10) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Diaper rash Defer I Pending Miscellaneous external Skin protectant Fever blister (topical) Defer I Pending Ophthalmic Ophthalmic Emollient I I 349.14(b)(6) Topical analgesic Skin protectant Skin protectant I I 347.10(r) Phenacaine hydrochloride Hemorrhoidal Anorectal Anesthetic (external) IIS IIS 310.545(a)(26)(vi) Hemorrhoidal Anorectal Anesthetic

(intrarectal) IIS IIS 310.545(a)(26)(vi)

Phenacetin Internal analgesic Internal analgesic Analgesic IIS IIS 310.545(a)(23)(i) Internal analgesic Internal analgesic Antipyretic IIS IIS 310.545(a)(23)(i) Internal analgesic Internal analgesic Antirheumatic IISE Not OTC 310.545(a)(23)(i) Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Miscellaneous internal Menstrual/diuretic Analgesic IIS IISE 310.545(a)(24)(i) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Phenindamine tartrate Cough/cold Cough/cold

(antihistamine) Antihistamine I I 341.12(i)

Miscellaneous internal Menstrual/diuretic Menstrual n/a IISE 310.545(a)(24)(i) Pheniramine maleate Cough/cold Cough/cold

(antihistamine) Antihistamine I I 341.12(j)

Internal analgesic Internal analgesic Analgesic adjuvant IIIE IIIE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antipyretic adjuvant IIIE IIIE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antirheumatic

adjuvant IIIE n/a 310.545(a)(23)(i)

Phenobarbital Cough/cold Cough/cold

(miscellaneous) Corrective IIIE IIS Pending

Phenol Antimicrobial I Antimicrobial First aid antiseptic n/a n/a Pending Antimicrobial I Antimicrobial Surgical hand scrub IIIE IIIE Pending Antimicrobial I Antimicrobial Surgical hand scrub IIS IIS Pending Antimicrobial I Antimicrobial Skin wound cleanser IIIE IIIE Pending Antimicrobial I Antimicrobial Skin antiseptic IIS IIS Pending Antimicrobial I Antimicrobial Skin wound

protectant IIIE IIIE Pending

Antimicrobial I Antimicrobial Antimicrobial soap IIS IIS Pending Antimicrobial I Antimicrobial Antimicrobial soap IIIE IIIE Pending Antimicrobial I Antimicrobial Skin wound

protectant n/a IIISE Pending

Antimicrobial I Antimicrobial Skin wound protectant

IIS IIS Pending

Review Panel Report Drug Category ANPR PR FR

Antimicrobial I Antimicrobial Preoperative skin prep IIS IIS Pending Antimicrobial I Antimicrobial Preoperative skin prep IIIE IIIE Pending Antimicrobial I Antimicrobial Skin wound cleanser IIS IIS Pending Antimicrobial I Antimicrobial First aid antiseptic n/a I Pending Antimicrobial I Antimicrobial Skin antiseptic IIIE IIIE Pending Antimicrobial I Antimicrobial Health care personnel

handwash IIIE IIIE Pending

Antimicrobial I Antimicrobial Health care personnel handwash

IIS IIS Pending

Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Antimicrobial II Antifungal Antifungal IISE IIISE 310.545(a)(22)(ii) Contraceptive/vaginal Vaginal Minor irritations IIISE Withdraw n/a Dental Relief of oral discomfort Toothache relief IIISE IIISE Pending Dental Relief of oral discomfort Oral mucosal

analgesic I I Pending

Hemorrhoidal Anorectal Antiseptic (intrarectal)

IISE IISE 310.545(a)(26)(ii)

Hemorrhoidal Anorectal Antiseptic (external) IISE IISE 310.545(a)(26)(ii) Miscellaneous external Antifungal Diaper rash Defer IISE 310.545(a)(22)(ii) Miscellaneous external Antimicrobial Diaper rash Defer IISE 310.545(a)(27)(ii) Miscellaneous external Boil treatment Boil treatment IISE IIISE 310.531(a) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis/ psoriasis

IIIE IIIE 310.545(a)(7)

Miscellaneous external External analgesic Astringent IISE n/a n/a Miscellaneous external External analgesic Diaper rash Defer IISE 310.545(a)(10)(iv) Miscellaneous external External analgesic Fever blister (topical) Defer I Pending Miscellaneous external External analgesic Insect bite/sting IISE I Pending Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer I Pending

Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Diaper rash Defer n/a 310.545(a)(27)(ii) Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(18)(v)(A) Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer IISE 310.545(a)(18)(vi)(A)

Oral cavity Oral health care Antimicrobial IIIE IIIE Pending Oral cavity Oral health care Analgesic/anesthetic I I Pending Topical analgesic External analgesic Analgesic/anesthetic I I Pending Phenol sulfonate Laxative Antiemetic Antiemetic IIIE IIE [52 FR 15891] Topical analgesic Sunscreen Sunscreen n/a n/a [64 FR 27682] Phenolate sodium ==== External analgesic Poison ivy/oak/

sumac n/a I Pending

Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Antimicrobial II Antifungal Antifungal IISE IIISE 310.545(a)(22)(ii) Contraceptive/vaginal Vaginal Minor irritations IISE Withdraw n/a Dental Relief of oral discomfort Toothache relief IIISE IIISE Pending Dental Relief of oral discomfort Oral mucosal

analgesic I I Pending

Hemorrhoidal Anorectal Antiseptic (external) IISE IISE 310.545(a)(26)(ii) Hemorrhoidal Anorectal Antiseptic

(intrarectal) IISE IISE 310.545(a)(26)(ii)

Miscellaneous external Dandruff/seborrheic dermatitis/psoriasis

Dandruff/seborrheic dermatitis/ psoriasis

IIIE IIIE 310.545(a)(7)

Miscellaneous external External analgesic Fever blister (topical) Defer I Pending Oral cavity Oral health care Antimicrobial IIIE IIIE Pending Topical analgesic External analgesic Analgesic/anesthetic I I Pending Phenolathalain, yellow Laxative Laxative Stimulant laxative I I/IIS 310.545(a)(12)(iv)(B) Phenolphthalein, white Laxative Laxative Stimulant laxative I I/IIS 310.545(a)(12)(iv)(B) Phenolphthalein, white [see phenolphthalein] ==== ==== ==== ==== ==== ==== Phenoxyacetic acid Miscellaneous external Corn/callus remover Corn/callus remover IIIE IIIE [55 FR 33261]

Review Panel Report Drug Category ANPR PR FR

Phenyl salicylate Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Antimicrobial II Antifungal Antifungal IIISE IIISE 310.545(a)(22)(ii) Laxative Antidiarrheal Antidiarrheal IIIE IIIE 310.545(a)(3)(i) Laxative Antiemetic Antiemetic IIIE IIE [52 FR 15891] Miscellaneous external Corn/callus remover Corn/callus remover IISE IISE [55 FR 33261] Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Phenylalanine Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Phenylbenzimidazole sulfonic acid

[see ensulizole] ==== ==== ==== ==== ==== ==== Phenylephrine bitartrate (in an effervescent

dosage form) n/a ==== Nasal decongestant

(oral) n/a n/a 341.20(a)(4)

Phenylephrine hydrochloride Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(oral) I I 341.20(a)(1)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (topical/inhalant))

I I 341.20(b)(8)

Hemorrhoidal Anorectal Vasoconstrictor (intrarectal)

I I 346.10(d)

Hemorrhoidal Anorectal Vasoconstrictor (external)

I I 346.10(d)

Oral cavity Oral health care Oral mucosal decongestant

IIIE IIIE Pending

Phenylephrine hydrochloride (0.08-0.2%) Ophthalmic Ophthalmic Vasoconstrictor I I 349.18(c) Phenylephrine hydrochloride (less than 0.08%) Ophthalmic Ophthalmic Vasoconstrictor IIIE IIIE 310.545(a)(21)(v) Phenylmercuric acetate Contraceptive/vaginal Contraceptive (vaginal) Contraceptive IIS Withdraw 310.545(a)(28) Phenylmercuric nitrate Contraceptive/vaginal Contraceptive (vaginal) Contraceptive IIS Withdraw 310.545(a)(28) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external Mercury First aid antiseptic n/a IIIE 310.545(a)(27)(i) Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Phenylpropanolamine bitartrate Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(oral) I II Pending

Phenylpropanolamine hydrochloride Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(oral) I II Pending

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (topical/inhalant)

IIIE II Pending

Miscellaneous internal Weight control Anorectic I I/IIS Pending Oral cavity Oral health care Oral mucosal

decongestant IIIE IIIE Pending

Phenylpropanolamine maleate Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(oral) I II Pending

Phenyltoloxamine citrate Internal analgesic Internal analgesic Antipyretic adjuvant IIIE IIIE Pending Internal analgesic Internal analgesic Antirheumatic

adjuvant IIIE n/a n/a

Phenyltoloxamine citrate [see phenyltoloxamine dihydrogen citrate]

==== ==== ==== ==== ==== ==== Phenyltoloxamine dihydrogen citrate Cough/cold Cough/cold

(antihistamine) Antihistamine IIIE IIIE 310.545(a)(6)(i)(B)

Miscellaneous external Skin protectant Poison ivy/oak/ sumac

Defer IISE 310.545(a)(18)(vi)

Review Panel Report Drug Category ANPR PR FR

Sedative Nighttime sleep aid Sleep aid IIISE IIISE [54 FR 6826] Sedative Nighttime sleep aid Sleep aid IIISE IIISE [54 FR 6826] Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IISE 310.545(a)(10)(vii)

Phosphate, disodium [see sodium phosphate, dibasic]

==== ==== ==== ==== ==== ==== Phosphate, monosodium [see sodium

phosphate, monobasic] ==== ==== ==== ==== ==== ==== Phosphorated carbohydrate Laxative Antiemetic Antiemetic IIIE IIIE [52 FR 15891] Phosphoric acid Dental Anticaries Anticavity agent IIE n/a 310.545(a)(2)(ii) Phosphorus Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Phytolacca Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Picrotoxin Miscellaneous external Pediculicide Pediculicide IISE IISE 310.545(a)(25)(i) Pine tar Cough/cold Cough/cold

(expectorant) Expectorant IIIE IIIE 310.545(a)(6)(iii)

Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis/ psoriasis

IIIE IIIE 310.545(a)(7)

Pine tar syrup Cough/cold Cough/cold

(expectorant) Expectorant IIIE IIIE 310.545(a)(6)(iii)

Pineapple enzymes Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Piperazine citrate Miscellaneous internal Antihelmintic Anthelmintic IIS IIS [51 FR 27758] Piperocaine hydrochloride Ophthalmic Ophthalmic Analgesic/anesthetic IIS IIS 310.545(a)(21)(i) Pipsissewa Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Piroctone olamine n/a TEA Dandruff n/a Piscidia erythrina Miscellaneous internal Menstrual/diuretic Dysmenorrhea IIE IIE 310.545(a)(24)(i) Plantago ovata husks [see psyllium husk] ==== ==== ==== ==== ==== ==== Plantago seed Laxative Laxative Bulk laxative I IISE Pending Miscellaneous internal Weight control Anorectic IIIE IISE 310.545(a)(20) Plantago seed husks [see psyllium seed husks] ==== ==== ==== ==== IISE Pending Plantago seed, blond [see plantago seed] ==== ==== ==== ==== IISE Pending Podophyllum resin Laxative Laxative Stimulant laxative IIS IIS 310.545(a)(12)(iv)(A) Poloxalkol [see polxamer 188] ==== ==== ==== ==== ==== ==== Poloxamer 188 Antimicrobial I Antimicrobial Skin wound cleanser n/a I Pending Laxative Laxative Stool softener IIIE IIIE 310.545(a)(12)(iii) Poloxamer 407 Dental Relief of oral discomfort Tooth desensitizer (in

combination only) IIIE IIIE Pending

Poloxamer-iodine complex Antimicrobial I Antimicrobial Surgical hand scrub IIISE IIISE Pending Antimicrobial I Antimicrobial Preoperative skin prep IIISE IIISE Pending Antimicrobial I Antimicrobial Antimicrobial soap n/a IISE Pending Antimicrobial I Antimicrobial Skin wound cleanser IIISE IIISE Pending

Review Panel Report Drug Category ANPR PR FR

Antimicrobial I Antimicrobial Skin antiseptic IIISE IIISE Pending Antimicrobial I Antimicrobial Skin protectant IIISE IIISE Pending Antimicrobial I Antimicrobial Health care personnel

handwash IIISE IIISE Pending

Polycarbophil Laxative Antidiarrheal Antidiarrheal I I 310.545(a)(3)(ii) Laxative Laxative Bulk laxative I I Pending Polycarbophil, calcium Laxative Antidiarrheal Antidiarrheal n/a I 310.545(a)(3)(ii) Laxative Laxative Bulk laxative n/a n/a n/a Polydimethylsiloxane and poloxamer ==== Gingivitis/plaque Antiplaque/gingivitis n/a IIIE Pending Polyethylene glycol 300 Ophthalmic Ophthalmic Demulcent I I 349.12(d)(2) Polyethylene glycol 400 Ophthalmic Ophthalmic Demulcent I I 349.12(d)(3) Polyethylene glycol 6000 Ophthalmic Ophthalmic Demulcent n/a IIIE 310.545(a)(21)(iv) Polymyxin B sulfate Antimicrobial II Antibiotic Skin wound

protectant I Defer n/a

Antimicrobial II Antibiotic First aid antibiotic IIIE I 333.120 [combos] Antimicrobial II Antibiotic Skin wound antibiotic I Defer n/a Polyoxyethylene laurate Miscellaneous external External analgesic Astringent IISE n/a n/a Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Polyoxyethylene monolaurate

[see polyoxyethylene laurate] ==== ==== ==== ==== ==== ==== Polysorbate 20 Miscellaneous external Hair growth/loss Hair grower n/a IIE 310.527(a) Polysorbate 60 Miscellaneous external Hair growth/loss Hair grower n/a IIE 310.527(a) Polysorbate 80 Ophthalmic Ophthalmic Demulcent I I 349.12(d)(4) Polyvinyl alcohol Ophthalmic Ophthalmic Demulcent I I 349.12(e) Polyvinylpyrrolidone [see povidone] ==== ==== ==== ==== ==== ==== Potassium acetate Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Potassium alum [see alum, potassium] ==== ==== ==== ==== ==== ==== Potassium aluminum sulfate [see alum,

potassium] ==== ==== ==== ==== ==== ==== Potassium bicarbonate Antacid Antacid Antacid n/a n/a 331.11(j)(1) Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Potassium bromide Sedative Nighttime sleep aid Sleep aid IISE IISE [54 FR 6826] Sedative Daytime sedative Sedative IIS IISE 310.519(a) Potassium carbonate Antacid Antacid Antacid n/a n/a 331.11(j)(1) Laxative Antidiarrheal Antidiarrheal IIE IIE 310.545(a)(3)(ii) Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Potassium chlorate Oral cavity Oral health care Antimicrobial IISE IISE Pending Potassium citrate Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Potassium extract Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Potassium ferrocyanide Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii)

Review Panel Report Drug Category ANPR PR FR

Potassium guaiacolsulfonate Cough/cold Cough/cold

(expectorant) Expectorant IIIE IIIE 310.545(a)(6)(iii)

Potassium iodide Cough/cold Cough/cold

(expectorant) Expectorant IIS IISE 310.545(a)(6)(iii)

Oral cavity Oral health care Expectorant IIS IIS 310.545(a)(6)(iii) Potassium nitrate Dental Relief of oral discomfort Tooth desensitizer IIIE I Pending Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Potassium sorbate Contraceptive/vaginal Vaginal Minor irritations I Withdraw n/a Povidone Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IISE 310.545(a)(18)(vi)(A)

Miscellaneous external Skin protectant Poison ivy/oak/ sumac

Defer IIE 310.545(a)(18)(vi)(A)

Ophthalmic Ophthalmic Demulcent I I 349.12(f) Povidone silver nitrate Miscellaneous internal Smoking deterrent Smoking deterrent n/a n/a 310.544(d) Povidone vinylacetate copolymers Miscellaneous external Skin protectant Poison ivy/oak/

sumac n/a n/a 310.545(a)(18)(vi)(A)

Povidone-iodine Antimicrobial I Antimicrobial Antiseptic n/a I Pending Antimicrobial I Antimicrobial Surgical hand scrub IIISE IIISE Pending Antimicrobial I Antimicrobial Antimicrobial soap n/a IIISE Pending Antimicrobial I Antimicrobial Skin protectant IIISE IIISE Pending Antimicrobial I Antimicrobial Skin wound cleanser IIISE IIISE Pending Antimicrobial I Antimicrobial Preoperative skin prep IIISE IIISE Pending Antimicrobial I Antimicrobial Skin antiseptic IIISE IIISE Pending Antimicrobial I Antimicrobial Health care personnel

handwash IIISE IIISE Pending

Antimicrobial II Acne Acne IIIE IIIE 310.545(a)(1) Antimicrobial II Antifungal Antifungal IIIE I 333.210(d) Contraceptive/vaginal Vaginal Minor irritations I Withdraw n/a Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis/ psoriasis

IIIE IIIE 310.545(a)(7)

Oral cavity Oral health care Antimicrobial IIISE IIISE Pending Povidone-iodine complex [see povidone-iodine] ==== ==== ==== ==== ==== ==== Pramoxine hydrochloride ==== External analgesic Poison ivy/oak/

sumac n/a I Pending

Hemorrhoidal Anorectal Anesthetic (external) I I 346.10(g) Hemorrhoidal Anorectal Anesthetic

(intrarectal) IIIE IIIE [55 FR 1779]

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Promethazine hydrochloride Cough/cold Cough/cold

(antihistamine) Antihistamine I IIIS [57 FR 58373]

Propionic acid Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(a)(22)(ii)

Review Panel Report Drug Category ANPR PR FR

Propyl benzoate Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Propyl p-benzoate Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Propylene glycol Miscellaneous external Pediculicide Pediculicide IISE IISE 310.545(a)(25)(i) Ophthalmic Ophthalmic Demulcent I I 349.12(d)(5) Miscellaneous external Hair growth/loss Hair grower IISE n/a 310.527(a) Propylhexidrine Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(topical/inhalant)) I I 341.20(b)(9)

Propylparaben Antimicrobial II Antifungal Antifungal IIISE IIISE 310.545(a)(22)(ii) Protease Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Protein Miscellaneous external Hair growth/loss Hair grower IISE n/a 310.527(a) Protein hydrolysate Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer IIISE 310.545(a)(18)(iii) Proteins [see protein] ==== ==== ==== ==== ==== ==== Prune concentrate dehydrate Laxative Laxative Stimulant laxative IIIE IIIE 310.545(a)(12)(iv)(A) Prune powder Laxative Laxative Stimulant laxative IIIE IIIE 310.545(a)(12)(iv)(A) Pseudoephedine sulfate Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(oral) I I 341.20(a)(3)

Pseudoephedrine hydrochloride Cough/cold Cough/cold

(bronchodilator) Bronchodilator nasal IIE IIE 310.545(a)(6)(iv)(A)

Cough/cold Cough/cold (nasal decongestant)

Decongestant (oral) I I 341.20(a)(2)

Pseudoephedrine sulfate Cough/cold Cough/cold

(bronchodilator) Bronchodilator IIE IIE 310.545(a)(6)(iv)(A)

Psyllium (hemicellulose) [see plantago seed] ==== ==== ==== ==== IISE Pending Psyllium hydrophilic mucilloid Laxative Laxative Bulk laxative I IISE Pending Psyllium seed Laxative Laxative Bulk laxative I IISE Pending Psyllium seed (blond) Laxative Laxative Bulk laxative I IISE Pending Psyllium seed husks Laxative Laxative Bulk laxative I IISE Pending Pyrantel pamoate Miscellaneous internal Antihelmintic Anthelmintic I I 357.110 Pyrethins [see pyrethrum extract] ==== ==== ==== ==== ==== ==== Pyrethrum extract (aerosol) with

piperonyl butoxide ==== Pediculicide Pediculicide n/a n/a 310.545(a)(25)(ii) Pyrethrum extract (nonaerosol) with

piperonyl butoxide Miscellaneous external Pediculicide Pediculicide I I 358.610 Pyridoxine hydrochloride Miscellaneous external External analgesic Fever blister (topical) Defer DEF Pending Miscellaneous external Skin protectant Fever blister (topical) Defer IISE 310.545(a)(18)(iv) Miscellaneous internal Menstrual/diuretic Premenstrual/menstrual

period IIIE IIIE Pending

Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20)

Review Panel Report Drug Category ANPR PR FR

Pyrilamine maleate Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Cough/cold Cough/cold

(antihistamine) Antihistamine I I 341.12(k)

adjuvant IIIE n/a 310.545(a)(23)(i)

Miscellaneous external External analgesic Insect bite/sting IISE IISE 310.545(a)(10)(vi) Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IISE 310.545(a)(10)(vii)

Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(18)(v)(A) Miscellaneous external Skin protectant Poison ivy/oak/

sumac n/a IISE Pending

Miscellaneous internal Menstrual/diuretic Antihistamine I IIISE Pending Oral cavity Oral health care Analgesic/anesthetic IIE IIE 310.545(a)(14) Sedative Nighttime sleep aid Sleep aid IIISE IIISE [54 FR 6826] Sedative Daytime sedative Sedative IIISE IISE 310.519(a) Pyrithione zinc Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff I I 358.710(a)(2)

Miscellaneous external Dandruff/seborrheic dermatitis/psoriasis

Dandruff I I 358.710(a)(3)

Miscellaneous external Dandruff/seborrheic dermatitis/psoriasis

Seborrheic dermatitis I I 358.710(b)(3)

Miscellaneous external Dandruff/seborrheic dermatitis/psoriasis

Seborrheic dermatitis I I 358.710(b)(2)

Quinine Internal analgesic Internal analgesic Analgesic IIS IIS 310.545(a)(23)(i) Internal analgesic Internal analgesic Antipyretic IIS IIS 310.545(a)(23)(i) Internal analgesic Internal analgesic Antirheumatic IISE Not OTC 310.545(a)(23)(i) Quinine ascorbate Miscellaneous internal Smoking deterrent Smoking deterrent IIE IIE 310.544(d) Quinine sulfate Miscellaneous internal Leg muscle cramp Nocturnal leg muscle

cramps IIISE IIISE 310.546

Racemethionine Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer IIISE 310.545(a)(18)(iii) Racephedrine hydrochloride Cough/cold Cough/cold

(bronchodilator) Bronchodilator I I 341.16(f)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (topical/inhalant)

I I 310.545(a)(6)(ii)(B)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (oral)

IIIE IIIE 310.545(a)(6)(ii)(B)

Racepinephrine hydrochloride Cough/cold Cough/cold

(bronchodilator) Bronchodilator n/a n/a 341.16(g)

Red petrolatum [see petrolatum, red] ==== ==== ==== ==== ==== ==== Released carbon dioxide [see carbon dioxide,

released] ==== ==== ==== ==== ==== ==== Reosote ==== Skin protectant Poison ivy/oak/

sumac n/a IISE 310.545(a)(18)(vi)(A)

Dental Relief of oral discomfort Toothache relief IIISE IIISE Pending Resorcinol ==== External analgesic Poison ivy/oak/

sumac n/a I Pending

==== n/a Dandruff/seborrheic dermatitis/ psoriasis

n/a n/a 310.545(a)(7)

Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Antimicrobial II Antifungal Antifungal IISE IISE 310.545(a)(22)(ii)

Review Panel Report Drug Category ANPR PR FR

Hemorrhoidal Anorectal Antiseptic (intrarectal)

IISE IISE 310.545(a)(26)(ii)

Hemorrhoidal Anorectal Keratolytic (external) I I 346.20(a) Hemorrhoidal Anorectal Keratolytic

(intrarectal) IISE IISE 346.20(a)

dermatitis/psoriasis Psoriasis IIE IIE [56 FR 63567]

Miscellaneous external External analgesic Diaper rash Defer IISE 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external External analgesic Fever blister (topical) Defer I Pending Topical analgesic External analgesic Analgesic/anesthetic I I Pending Resorcinol monoacetate Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Rhubarb fluidextract Laxative Antidiarrheal Antidiarrheal IISE IISE 310.545(a)(3)(ii) Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Rhubarb, chinese Laxative Laxative Stimulant laxative IIISE IIISE 310.545(a)(12)(iv)(A) Riboflavin Miscellaneous internal Menstrual/diuretic Premenstrual/menstrual

period n/a IISE 310.545(a)(24)(i)

Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Rice polishings Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Rose petals, infusion of Ophthalmic Ophthalmic Astringent IIIE IIIE 310.545(a)(21)(iii) Rosin Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Rosin cerate Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Sabadilla alkaloids Miscellaneous external Pediculicide Pediculicide IISE IISE 310.545(a)(25)(i) Sabel, liposterolic extract of Miscellaneous internal Benign prostatic

hypertrophy Benign prostatic

hypertrophy n/a n/a 310.532(a)

Saccharin Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Sage oil Miscellaneous external Skin protectant Astringent n/a IISE 310.545(a)(18)(ii) Salicyl alcohol Oral cavity Oral health care Analgesic/anesthetic I I Pending Salicylamide ==== External analgesic Poison ivy/oak/

sumac n/a IIIE 310.545(a)(10)(vii)

Internal analgesic Internal analgesic Analgesic adjuvant IIISE IIISE Pending Internal analgesic Internal analgesic Analgesic IIISE IIISE Pending Internal analgesic Internal analgesic Antipyretic adjuvant IIISE IIISE Pending Internal analgesic Internal analgesic Antipyretic IIISE IIISE Pending Internal analgesic Internal analgesic Antirheumatic

adjuvant IIISE n/a n/a

Internal analgesic Internal analgesic Antirheumatic IISE Not OTC n/a Miscellaneous external External analgesic Fever blister (topical) Defer IIIE 310.545(a)(10)(v) Miscellaneous internal Menstrual/diuretic Analgesic IIISE IIISE Pending Sedative Nighttime sleep aid Sleep aid IIE IIE [54 FR 6826] Sedative Daytime sedative Sedative IIE IISE 310.519(a) Topical analgesic External analgesic Analgesic/anesthetic IIIE IIIE 310.545(a)(10)(i) Salicylic acid Antimicrobial II Acne Acne IIIE I 333.310(c) Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(a)(22)(ii) Antimicrobial II Acne Acne IISE IISE 310.545(a)(1) Miscellaneous external Antifungal Diaper rash Defer IISE 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff I I 358.710(a)(4)

Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv)

Review Panel Report Drug Category ANPR PR FR

Miscellaneous external External analgesic Poison ivy/oak/ sumac

Defer IISE 310.545(a)(10)(vii)

Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer IISE 310.545(a)(18)(vi)(A)

Miscellaneous external Corn/callus remover Corn/callus remover I I 358.510(a) Miscellaneous external Wart remover Wart remover I IISE 358.110(a) Miscellaneous external Wart remover Wart remover I I 358.110(b) Miscellaneous external Wart remover Wart remover I I 358.110(c) Miscellaneous external Corn/callus remover Corn/callus remover I I 358.510 (b) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Seborrheic dermatitis I I 358.710(b)(4)

Miscellaneous external Dandruff/seborrheic dermatitis/psoriasis

Psoriasis I I 358.710(c)(2)

Salsalate Internal analgesic Internal analgesic Analgesic IIISE IIISE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antipyretic IIISE IIISE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antirheumatic IIISE Not OTC 310.545(a)(23)(i) Sanguinaria extract ==== Gingivitis/plaque Gingivitis/antiplaque n/a IIIE Pending Sarsaparrilla Miscellaneous internal Aphrodisiac Aphrodisiac IISE IISE 310.528(a) Sassafras oil Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Saw palmetto Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Scopolamine aminoxide hydrobromide Sedative Nighttime sleep aid Sleep aid IISE IIS [54 FR 6826] Sedative Daytime sedative Sedative IISE IISE 310.519(a) Scopolamine hydrobromide Laxative Antidiarrheal Antidiarrheal IIE IIE 310.545(a)(3)(i) Laxative Antiemetic Antiemetic n/a IIIE [52 FR 15891] Sedative Nighttime sleep aid Sleep aid IISE IIS [54 FR 6826] Sedative Daytime sedative Sedative IISE IISE 310.519(a) Sea kelp [see kelp] ==== ==== ==== ==== ==== ==== Sea minerals Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Selenium sulfide Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff I I 358.710(a)(5)

Miscellaneous external Dandruff/seborrheic dermatitis/psoriasis

Seborrheic dermatitis I I 358.710(b)(5)

Selenium sulfide, micronized Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff n/a I 358.710(a)(6)

Senecio aureus Miscellaneous internal Menstrual/diuretic Dysmenorrhea IISE IISE 310.545(a)(24)(i) Senna Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(8)(ii)

Senna fluidextract Laxative Laxative Stimulant laxative I I/IIIS Pending Senna pod concentrate Laxative Laxative Stimulant laxative I I/IIIS Pending Senna syrup Laxative Laxative Stimulant laxative I I/IIIS Pending Sennosides A and B [see sennosides] ==== ==== ==== ==== ==== ==== Sennosides A and B Laxative Laxative Stimulant laxative I I/IIIS Pending Sesame oil Miscellaneous external External analgesic Fever blister (topical) Defer n/a Pending Miscellaneous external Skin protectant Fever blister (topical) Defer n/a Pending Sesame seed Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20)

Review Panel Report Drug Category ANPR PR FR

Shark liver oil ==== Insect bite/sting Insect bite/sting n/a n/a 310.545(a)(18)(v)(B) ==== Poison ivy/oak/sumac Poison ivy/oak/

sumac n/a n/a 310.545(a)(18)(vi)(B)

==== Skin protectant Fever blister (topical) n/a I Pending Hemorrhoidal Anorectal Wound healing agent

(intrarectal) IIIE IIIE 310.545(a)(26)(x)

Hemorrhoidal Anorectal Protectant (intrarectal)

I I 346.14(b)(3)

Hemorrhoidal Anorectal Wound healing agent (external)

IIIE IIIE 310.545(a)(26)(x)

Hemorrhoidal Anorectal Protectant (external) I I 346.14(b)(3) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Protectant I I Pending Miscellaneous external Skin protectant Diaper rash Defer IIISE Pending Topical analgesic Skin protectant Skin protectant I I 310.545(a)(18)(i)(B) Silicone Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Silver acetate Miscellaneous internal Smoking deterrent Smoking deterrent IIIE IIIE 310.544(d) Silver nitrate Miscellaneous external External analgesic Astringent IISE n/a n/a Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous internal Smoking deterrent Smoking deterrent IISE IISE 310.544(d) Silver protein, mild Ophthalmic Ophthalmic Anti-infective IIIE IIIE 310.545(a)(21)(ii) Simethicone Antacid Antacid Antacid IIIE IIE [39 FR 19873] Antacid Antiflatulent Antiflatulent IIIE I 332.10 Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IISE 310.545(a)(10)(vii)

Miscellaneous external Skin protectant Poison ivy/oak/ sumac

Defer IISE 310.545(a)(18)(vi)(A)

Miscellaneous internal Digestive aid Digestive aid (intestinal distress)

IIIE IIIE [58 FR 54454]

Miscellaneous internal Digestive aid Digestive aid (ippuad) IIIE IIIE [58 FR 54454] Sodium Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Sodium 3, 4-dimethylphenyl-glyoxylate Topical analgesic Sunscreen Sunscreen IISE IISE [64 FR 27682] Sodium acetylsalicylate Miscellaneous internal Overindulgence in

alcohol/food Overindulgence

remedies (hangover)

I I Pending

Sodium aluminum chlorohydroxy lactate (aerosol)

Antiperspirant Antiperspirant Antiperspirant IIISE IIISE 310.545(a)(4) Sodium aluminum chlorohydroxy lactate

(nonaerosol) Antiperspirant Antiperspirant Antiperspirant IIIE IIIE 310.545(a)(4) Sodium aminobenzoate Internal analgesic Internal analgesic Analgesic adjuvant IISE IISE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antipyretic adjuvant IISE IISE 310.545(a)(23)(i) Internal analgesic Internal analgesic Antirheumatic

adjuvant IISE n/a 310.545(a)(23)(i)

Sodium benzoate Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Sodium bicarbonate ==== Gingivitis/plaque Gingivitis/antiplaque n/a IIIE Pending Antacid Antacid Antacid I I 331.11(k)(1) Contraceptive/vaginal Vaginal Alters vaginal pH IIIE Withdraw n/a Dental Anticaries Anticavity agent IIE IIE [60 FR 52504] Internal analgesic Internal analgesic Corrective I n/a n/a

Review Panel Report Drug Category ANPR PR FR

sumac Defer n/a n/a

Miscellaneous external Skin protectant Diaper rash Defer IIISE Pending Miscellaneous external Skin protectant Insect bite/sting IISE IISE Pending Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer I Pending

Miscellaneous internal Digestive aid Digestive aid (ippuad) IIIE IIIE 310.545(a)(8)(i) Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) IIIE IIIE 310.545(a)(8)(i)

Miscellaneous internal Weight control Anorectic IIIE IISE 310.545(a)(20) Oral cavity Oral health care Debriding agent I I Pending Topical analgesic Skin protectant Skin protectant I I 347.10(O) Sodium borate Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(a)(22)(ii) Contraceptive/vaginal Vaginal Lowers surface

tension mucolytic effects

IIISE Withdraw n/a

Contraceptive/vaginal Vaginal Minor irritations IIISE Withdraw n/a Contraceptive/vaginal Vaginal Alters vaginal pH IIISE Withdraw n/a Contraceptive/vaginal Vaginal Astringent IIISE Withdraw n/a Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis/ psoriasis

IIE IIE 310.545(a)(7)

Miscellaneous external External analgesic Astringent n/a n/a n/a Miscellaneous external External analgesic Insect bite/sting IISE IISE 310.545(a)(10)(vi) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(18)(v)(A) Oral cavity Oral health care Debriding agent IISE IISE Pending Sodium borate monohydrate Dental Oral mucosal injury Skin wound cleanser IISE IISE Pending Sodium bromide Sedative Nighttime sleep aid Sleep aid IISE IISE [54 FR 6826] Sedative Daytime sedative Sedative IIS IISE 310.519(a) Sodium caprylate Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(a)(22)(ii) Oral cavity Oral health care Antimicrobial IIIE IIIE Pending Sodium carbonate Antacid Antacid Antacid I I 331.11(k)(1) Contraceptive/vaginal Vaginal Alters vaginal pH IIISE Withdraw n/a Internal analgesic Internal analgesic Corrective I n/a n/a Sodium caseinate Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Sodium chloride Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Ophthalmic Ophthalmic Hypertonic agent I I 349.16 Sodium citrate Cough/cold Cough/cold

(expectorant) Expectorant IIIE IIIE 310.545(a)(6)(iii)

Dental Relief of oral discomfort Tooth desensitizer (in combination only)

IIIE IIIE Pending

Miscellaneous internal Digestive aid Digestive aid (intestinal distress)

IIIE IIIE 310.545(a)(8)(i)

Miscellaneous internal Digestive aid Digestive aid (ippuad) IIIE IIIE 310.545(a)(8)(i) Sodium citrate in solution Miscellaneous internal Overindulgence in

alcohol/food Overindulgence

remedies (hangover)

I I Pending

Miscellaneous internal Overindulgence in alcohol/food

Overindulgence remedies (hangover)

I I Pending

Review Panel Report Drug Category ANPR PR FR

Sodium diacetate Miscellaneous external External analgesic Astringent IISE n/a n/a Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Sodium dichromate Oral cavity Oral health care Antimicrobial IIS IISE Pending Sodium dihydrogen phosphate [see sodium

phosphate, monobasic] ==== ==== ==== ==== ==== ==== Sodium fluoride Dental Anticaries Anticavity dentrifrice I I 355.10(a)(2) Dental Anticaries Anticavity dental rinse I I 355.10(a)(3)(iv) Dental Anticaries Anticavity dental rinse I I 355.10(a)(3)(v) Dental Anticaries Anticavity dentrifrice I I 355.10(a)(1) Dental Anticaries Anticavity dental rinse I I 355.10(a)(3)(iii) Dental Relief of oral discomfort Tooth desensitizer (in

combination only) IISE IISE Pending

Dental Relief of oral discomfort Tooth desensitizer IIIE IIIE Pending Sodium lactate Contraceptive/vaginal Vaginal Alters vaginal pH IIIE Withdraw n/a Sodium lauryl sulfate Contraceptive/vaginal Vaginal Lowers surface

tension mucolytic effects

I Withdraw n/a

Sodium monoflurorophosphate Dental Anticaries Anticavity dentrifrice I I 355.10(b)(1) Dental Anticaries Anticavity dental rinse IIS IIS 310.545(a)(2)(i) Dental Relief of oral discomfort Tooth desensitizer IIIE IIIE Pending Dental Anticaries Anticavity dentrifrice I I 355.10(b)(2) Sodium nitrate Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Sodium oleate Laxative Laxative Stimulant laxative IIIE IIIE 310.545(a)(12)(iv)(A) Sodium perborate Contraceptive/vaginal Vaginal Alters vaginal pH IIISE Withdraw n/a Contraceptive/vaginal Vaginal Astringent IIISE Withdraw n/a Contraceptive/vaginal Vaginal Lowers surface

tension mucolytic effects

IIISE Withdraw n/a

Contraceptive/vaginal Vaginal Minor irritations IIISE Withdraw n/a Oral cavity Oral health care Debriding agent IIISE IIISE Pending Sodium perborate monohydrate Dental Oral health care Wound cleanser IISE I Pending Sodium phosphate [see sodium phosphate,

dibasic] ==== ==== ==== ==== ==== ==== Sodium phosphate, dibasic Dental Anticaries Anticavity agent IIE IIE 310.545(a)(2)(ii) Laxative Laxative saline laxative I I Pending Sodium phosphate, dibasic anhydrous reagent

[see sodium phosphate, dibasic] ==== ==== ==== ==== ==== ==== Sodium phosphate, monobasic Dental Anticaries Anticavity agent IIE IIE 310.545(a)(2)(ii) Laxative Laxative Saline laxative I I Pending Sodium picosulfate n/a TEA Laxative n/a Sodium potassium tartrate Antacid Antacid Antacid I I 331.11(j)(2)

331.11(k)(2) Sodium potassium tartrate [see potassium

sodium tartrate] ==== ==== ==== ==== ==== ==== Sodium propionate Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(a)(22)(ii) Contraceptive/vaginal Vaginal Minor irritations I Withdraw n/a Miscellaneous external Antifungal Diaper rash Defer IISE 310.545(a)(22)(ii) Miscellaneous external Antimicrobial Diaper rash Defer IIISE Pending

Review Panel Report Drug Category ANPR PR FR

Sodium salicylate Contraceptive/vaginal Vaginal Minor irritations IISE Withdraw n/a Internal analgesic Internal analgesic Analgesic I I Pending Internal analgesic Internal analgesic Antipyretic I I Pending Internal analgesic Internal analgesic Antirheumatic I Not OTC n/a Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis/ psoriasis

IIIE IIIE 310.545(a)(7)

Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Miscellaneous internal Menstrual/diuretic Analgesic I I Pending Miscellaneous internal Menstrual/diuretic Diuretic IIIE IIIE 310.545(a)(24)(i) Miscellaneous internal Overindulgence in

alcohol/food Overindulgence

remedies (hangover)

I I Pending

Sodium salicylate acid phenolate Hemorrhoidal Anorectal Antiseptic

(intrarectal) IISE IISE 310.545(a)(26)(ii)

Hemorrhoidal Anorectal Antiseptic (external) IISE IISE 310.545(a)(26)(ii) Contraceptive/vaginal Vaginal Minor irritations IISE Withdraw n/a Sodium sulfide Miscellaneous external Ingrown toenail Ingrown toenail n/a I 538.310 Miscellaneous external Ingrown toenail Ingrown toenail IIIE IIIE 310.538(a) [removed 68

FR 24348] Sodium thiosulfate Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Sorbitan monostearate Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Sorbitan sesquioleate Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Sorbitol Laxative Laxative Hyperosmotic laxative I I Pending Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) IIE IIE 310.545(a)(8)(i)

Miscellaneous internal Digestive aid Digestive aid (ippuad) IIE IIE 310.545(a)(8)(i) Oral cavity Oral health care Oral health care

nonantimicrobial n/a n/a 310.545(a)(14)

Soyasterol Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Soybean oil, hydrogenated Miscellaneous internal Cholecystokinetic Cholecystokinetic n/a n/a 357.210(b) Soybean protein Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Soymeal Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Spermaceti Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Squill Cough/cold Cough/cold

(expectorant) Expectorant IISE IISE 310.545(a)(6)(iii)

Squill extract Cough/cold Cough/cold

(expectorant) Expectorant IISE IISE 310.545(a)(6)(iii)

Stannous fluoride ==== Antigingivitis Antigingivitis I ===== Pending Dental Anticaries Anticavity dental gel I I 355.10(c)(2) Dental Anticaries Anticavity dentrifrice I I 355.10(c)(1) Dental Anticaries Anticavity dental rinse I I 355.10(c)(3) Dental Relief of oral discomfort Tooth desensitizer IIIE IIIE Pending Stannous pyrophosphate and zinc citrate ==== Gingivitis/plaque Antiplaque/gingivitis n/a IIIE Pending

Review Panel Report Drug Category ANPR PR FR

Stearly alcohol ==== Insect bite/sting Insect bite/sting n/a n/a 310.545(a)(18)(v)(B) ==== Poison ivy/oak/sumac Poison ivy/oak/

sumac n/a n/a 310.545(a)(18)(vi)(B)

==== Skin protectant Skin protectant n/a n/a 310.545(a)(18)(i)(B) Stem bromelain Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Strawberry Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Strontium chloride Dental Relief of oral discomfort Tooth desensitizer (in

combination only) IISE IISE Pending

Dental Relief of oral discomfort Tooth desensitizer IIIE IIIE Pending Strychnine Miscellaneous internal Aphrodisiac Aphrodisiac IISE IISE 310.528(a) Miscellaneous internal Digestive aid Digestive aid (ippuad) n/a n/a 310.545(a)(18)(ii) Sucrose Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Sucrose octaacetate Miscellaneous external Nailbiting/thumbsucking Nailbiting/

thumbsucking deterrent

IIIE IIIE 310.536(a)

Sugars Oral cavity Oral health care Oral health care

nonantimicrobial n/a n/a 310.545(a)(14)

Sulfacetamide sodium Miscellaneous external Hair growth/loss Hair grower n/a n/a 310.527(a) Ophthalmic Ophthalmic Anti-infective IIS IIS 310.545(a)(21)(ii) Sulfur ==== External analgesic Poison ivy/oak/

sumac n/a IIE 310.545(a)(10)(vii)

==== Skin protectant Wound healing agent n/a n/a 310.545(a)(18)(i)(A) Antimicrobial II Acne Acne I I 333.310(d) Antimicrobial II Acne Acne I I 333.310(e) Miscellaneous external Boil treatment Boil treatment n/a IIISE 310.531(a) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff I I 358.710(a)(7)

Miscellaneous external Skin protectant Diaper rash Defer IISE 310.545(a)(18)(iii) Miscellaneous external Skin protectant Fever blister (topical) Defer IISE 310.545(a)(18)(iv) Topical analgesic Skin protectant Skin protectant IISE IISE 310.545(a)(18)(i)(A) Sulfur (paraffinic hydrocarbons) Miscellaneous external Hair growth/loss Hair grower n/a IIE 310.527(a) Sulfur, precipitated Hemorrhoidal Anorectal Keratolytic (external) IIIE IIIE 310.545(a)(26)(v) Hemorrhoidal Anorectal Keratolytic

(intrarectal) IIE IIE 310.545(a)(26)(v)

Sulfur, sublimed Hemorrhoidal Anorectal Keratolytic

(intrarectal) IIE IIE 310.545(a)(26)(v)

Hemorrhoidal Anorectal Keratolytic (external) IIIE IIIE 310.545(a)(26)(v) Miscellaneous external Pediculicide Pediculicide IISE IISE 310.545(a)(25)(i) Sulfurated oils of turpentine Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Sulisobenzone Topical analgesic Sunscreen Sunscreen I I 352.10(o) Sweet spirits of nitre Miscellaneous external Sweet spirits of nitre All indications IISE n/a 310.502(a)(12) Syrup of pine tar [see pine tar syrup] ==== ==== ==== ==== ==== ==== Talc ==== Antimicrobial Diaper rash n/a n/a Pending Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external External analgesic Astringent IISE n/a n/a Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Diaper rash Defer I Pending

Review Panel Report Drug Category ANPR PR FR

Talcum powder Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Tannic acid ==== Skin protectant Diaper rash n/a IISE 310.545(a)(18)(iii) ==== Skin protectant Wound healing agent n/a n/a 310.545(a)(18)(i) Antimicrobial II Antifungal Antifungal IIE IIE 310.545(a)(22)(ii) Hemorrhoidal Anorectal Astringent (external) IISE IISE 310.545(a)(26)(iii) Hemorrhoidal Anorectal Anorectal (intrarectal) IISE IISE 310.545(a)(26)(iii) Miscellaneous external External analgesic Fever blister (topical) Defer IIISE 310.545(a)(10)(v) Miscellaneous external External analgesic Insect bite/sting n/a IIIE Pending Miscellaneous external External analgesic Poison ivy/oak/sumac Defer IIIE 310.545(a)(10)(vii) Miscellaneous external Ingrown toenail Ingrown toenail IIIE IIIE 310.538(a) Miscellaneous external Ingrown toenail Astringent(external) IIIE IIIE 310.538(a) Miscellaneous external Skin protectant Fever blister (topical) Defer IIISE 310.545(a)(18)(iv) Miscellaneous external Skin protectant Poison ivy/oak/sumac Defer IISE 310.545(a)(18)(vi)(A) Miscellaneous internal Digestive aid Digestive aid (intestinal

distress) n/a n/a 310.545(a)(8)(ii)

Topical analgesic Skin protectant Skin protectant IISE IISE 310.545(a)(18)(i)(A) Tannic acid glycerite Miscellaneous external External analgesic Astringent IISE n/a n/a Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Tar oil Miscellaneous external Hair growth/loss Hair grower IISE n/a 310.527(a) Taraxacum officinale Miscellaneous external Menstrual/diuretic Dysmenorrhea IIE IIE 310.545(a)(24)(i) Tartaric acid Antacid Antacid Antacid I I 331.11(m) Contraceptive/vaginal Vaginal Alters vaginal pH IIIE Withdraw n/a Laxative Laxative Saline laxative IIISE IIISE 310.545(a)(12)(ii) Terpin hydrate Cough/cold Cough/cold (expectorant) Expectorant IIIE IIIE 310.545(a)(6)(iii) Terpin hydrate elixir Cough/cold Cough/cold (expectorant) Expectorant IIIE IIIE 310.545(a)(6)(iii) Testosterone Miscellaneous internal Aphrodisiac Aphrodisiac IIS IIS 310.528(a) Tetracaine ==== External analgesic Poison ivy/oak/sumac n/a I Pending Hemorrhoidal Anorectal Anesthetic (external) IIIE I 346.10(h) Hemorrhoidal Anorectal Anesthetic (intrarectal) IIIE IIIE [55 FR 1779] Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer IISE 310.545(a)(10)(iv) Miscellaneous external External analgesic Fever blister (topical) Defer I Pending Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Oral cavity Oral health care Analgesic/anesthetic IIS IIS 310.545(a)(14) Topical analgesic External analgesic Analgesic/anesthetic I I Pending Tetracaine hydrochloride ==== External analgesic Poison ivy/oak/sumac n/a I Pending Antimicrobial II Acne Acne IISE IISE 310.545(a)(1) Hemorrhoidal Anorectal Anesthetic (external) IIIE I 346.10(i) Hemorrhoidal Anorectal Anesthetic (intrarectal) IIIE IIIE [55 FR 1779] Miscellaneous external External analgesic Fever blister (topical) Defer I Pending Miscellaneous external Hair growth/loss Hair grower IIE IIE 310.527(a) Oral cavity Oral health care Analgesic/anesthetic IIS IIS 310.545(a)(14) Topical analgesic External analgesic Analgesic/anesthetic I I Pending Tetracycline hydrochloride Antimicrobial II Antibiotic First aid antibiotic n/a I 333.110(f) Antimicrobial II Antibiotic Skin wound antibiotic IIIE Defer n/a Antimicrobial II Antibiotic Skin wound protectant I Defer n/a Tetrahydrozoline

hydrochloride Ophthalmic Ophthalmic Vasoconstrictor I I 349.18(d) Thenyldiamine hydrochloride Cough/cold Cough/cold (antihistamine) Antihistamine IIIE IIIE 310.545(a)(6)(i)(A)&(B) Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant

(topical/inhalant) IIIE IIIE [59 FR 43408]

Review Panel Report Drug Category ANPR PR FR

Theobromine sodium salicylate Miscellaneous internal Menstrual/diuretic Diuretic IIIE IIIE 310.545(a)(24)(i) Theophylline Miscellaneous internal Menstrual/diuretic Diuretic IIIE IIIE 310.545(a)(24)(i) Theophylline (all combinations) Cough/cold Cough/cold

(bronchodilator) Bronchodilator n/a n/a 310.545(a)(6)(iv)(B)

Theophylline anhydrous [see theophylline, anhydrous]

==== ==== ==== ==== ==== ==== Theophylline anhydrous [see theophylline] ==== ==== ==== ==== ==== ==== Theophylline calcium salicylate Cough/cold Cough/cold

(bronchodilator) Bronchodilator I IIS 310.545(a)(6)(iv)(A)

Theophylline sodium glycinate Cough/cold Cough/cold

(bronchodilator) Bronchodilator I IIS 310.545(a)(6)(iv)(A)

Theophylline, anhydrous Cough/cold Cough/cold

(bronchodilator) Bronchodilator I IIS 310.545(a)(6)(iv)(A)

Thiamine Miscellaneous internal Oral insect repellant Insect repellent IIE IIE 310.529(a) Thiamine hydrochloride Miscellaneous external Hair growth/loss Hair grower n/a n/a 310.527(a) Miscellaneous internal Menstrual/diuretic Menstrual n/a IISE 310.545(a)(24)(i) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Sedative Nighttime sleep aid Sleep aid IIE IIE [54 FR 6826] Sedative Daytime sedative Sedative IIE IISE 310.519(a) Thiamine mononitrate Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Thimerosal Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Miscellaneous external Mercury First aid antiseptic n/a IISE 310.545(a)(27)(i) Thiocyanoacetate ==== Pediculicide Pediculicide n/a n/a 310.545(a)(25)(i) Thonzylamine hydrochloride Cough/cold Cough/cold

(antihistamine) Antihistamine I I 341.12(l)

Threonine Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Thyme oil, white Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Thymol ==== External analgesic Poison ivy/oak/

sumac n/a IIIE 310.545(a)(10)(vii)

Antimicrobial II Acne Acne IIE IIIE 310.545(a)(1) Antimicrobial II Antifungal Antifungal IIISE IIISE 310.545(a)(22)(ii) Cough/cold Cough/cold

(antihistamine) Antitussive

(topical/inhalant) IIIE IIIE [52 FR 30055]

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (inhalant room spray)

IIIE IIIE 310.545(a)(6)(ii)(A)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (topical/inhalant)

IIIE IIIE 310.545(a)(6)(ii)(A)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (lozenge)

IIIE IIIE 310.545(a)(6)(ii)(A)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (mouthwash)

IIIE IIIE 310.545(a)(6)(ii)(A)

Dental Relief of oral discomfort Toothache relief IIIE IIIE Pending Dental Relief of oral discomfort Oral mucosal

analgesic IIIE IIIE Pending

Review Panel Report Drug Category ANPR PR FR

Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis/ psoriasis

IIIE IIIE 310.545(a)(7)

Miscellaneous external External analgesic Astringent IISE n/a n/a Miscellaneous external External analgesic Fever blister (topical) Defer IIISE 310.545(a)(10)(v) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Miscellaneous internal Smoking deterrent Smoking deterrent IIE IIE 310.544(d) Oral cavity Oral health care Antimicrobial IIIE IIIE Pending Oral cavity Oral health care Analgesic/anesthetic IIIE IIIE 310.545(a)(14) Topical analgesic External analgesic Analgesic/anesthetic IIIE IIIE 310.545(a)(10)(i) Thymol iodide Dental Relief of oral discomfort Oral mucosal

analgesic IIIE IIIE Pending

Dental Relief of oral discomfort Toothache relief IIIE IIIE Pending Oral cavity Oral health care Antimicrobial IIISE IIISE Pending Tincture of impatiens bi-flora [see impatiens

bi-flora tincture] ==== ==== ==== ==== ==== ==== Tincture of iodine [see iodine tincture] ==== ==== ==== ==== ==== ==== Titanium dioxide Miscellaneous external External analgesic Fever blister (topical) Defer n/a Pending Miscellaneous external Skin protectant Fever blister (topical) Defer v n/a Topical analgesic Sunscreen I I 352.10(p) Tolindate Antimicrobial II Antifungal Antifungal IISE IISE 310.545(a)(22)(ii) Tolnaftate Antimicrobial II Antifungal Antifungal I I 333.210(e) Tolu Cough/cold Cough/cold

(expectorant) Expectorant IIIE IIIE 310.545(a)(6)(iii)

Tolu balsam Cough/cold Cough/cold

(expectorant) Expectorant IIIE IIIE 310.545(a)(6)(iii)

Oral cavity Oral health care Antimicrobial IIIE IIIE Pending Oral cavity Oral health care Expectorant IIIE n/a 310.545(a)(6)(iii) Tolu balsam tincture Cough/cold Cough/cold

(expectorant) Expectorant IIIE IIIE 310.545(a)(6)(iii)

Topical starch ==== Skin protectant Poison ivy/oak/

sumac n/a IIIE 310.545(a)(18)(vi)(A)

Hemorrhoidal Anorectal Protectant (external) I I 346.14(9) Hemorrhoidal Anorectal Protectant

(intrarectal) I I 346.14(9)

Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Astringent IISE IISE Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Diaper rash Defer I Pending Miscellaneous external Skin protectant Fever blister (topical) Defer IIISE 310.545(a)(18)(iv) Topical analgesic Skin protectant Skin protectant I Defer 347.10(q) Triacetin Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(a)(22)(ii) Tribromsalan Antimicrobial I Antimicrobial Antimicrobial IIS n/a 310.502(a)(5) Tricalcium phosphate Antacid Antacid Antacid n/a n/a 331.11(i)(3) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Tricalcium phosphate [see calcium phosphate,

tribasic] ==== ==== ==== ==== ==== ====

Review Panel Report Drug Category ANPR PR FR

Triclocarban Antimicrobial I Antimicrobial Skin antiseptic n/a IIIE Pending Antimicrobial I Antimicrobial Skin wound cleanser IISE IIISE Pending Antimicrobial I Antimicrobial Antimicrobial soap IIISE IIISE Pending Antimicrobial I Antimicrobial Preoperative skin prep IISE IISE Pending Antimicrobial I Antimicrobial Surgical hand scrub IISE IISE Pending Antimicrobial I Antimicrobial Skin antiseptic IISE IISE Pending Antimicrobial I Antimicrobial Skin protectant IISE IISE Pending Antimicrobial I Antimicrobial Health care personnel

handwash IIISE IIISE Pending

Triclosan Antimicrobial I Antimicrobial Skin antiseptic n/a IIIE Pending Antimicrobial I Antimicrobial Antimicrobial soap IIISE IIISE Pending Antimicrobial I Antimicrobial Preoperative skin prep IISE IIISE Pending Antimicrobial I Antimicrobial Surgical hand scrub IISE IIISE Pending Antimicrobial I Antimicrobial Skin wound cleanser IIISE IIISE Pending Antimicrobial I Antimicrobial Skin antiseptic IIISE IIISE Pending Antimicrobial I Antimicrobial Skin protectant IIISE IIISE Pending Antimicrobial I Antimicrobial Health care personnel

handwash IISE IIISE Pending

Miscellaneous external Antimicrobial Diaper rash Defer IIISE Pending Miscellaneous external Boil treatment Boil treatment n/a n/a 310.531(a) n/a TEA Acne n/a n/a TEA Antigingivitis n/a Trillium Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Tripelennamine hydrochloride ==== External analgesic Poison ivy/oak/

sumac n/a I Pending

Cough/cold Cough/cold (antihistamine)

Antihistamine n/a n/a [57 FR 58373]

Miscellaneous external External analgesic Fever blister (topical) Defer IIIE 310.545(a)(10)(v) Topical analgesic External analgesic Analgesic/anesthetic I I Pending Triple dye Antimicrobial I Antimicrobial Skin antiseptic n/a IIISE Pending Antimicrobial I Antimicrobial Antimicrobial soap n/a IISE Pending Antimicrobial I Antimicrobial Preoperative skin prep n/a IISE Pending Antimicrobial I Antimicrobial Surgical hand scrub n/a IISE Pending Antimicrobial I Antimicrobial Skin antiseptic IIISE IIISE Pending Antimicrobial I Antimicrobial Skin protectant n/a IISE Pending Antimicrobial I Antimicrobial Skin wound cleanser n/a IISE Pending Antimicrobial I Antimicrobial Health care personnel

handwash n/a IIISE Pending

Triprolidine hydrochloride Cough/cold Cough/cold

(antihistamine) Antihistamine n/a I 341.12(m)

Triticum Miscellaneous internal Menstrual/diuretic Menstrual n/a IISE 310.545(a)(24)(i) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Trolamine Miscellaneous external External analgesic Insect bite/sting IIIE IISE Pending Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer n/a Pending

Miscellaneous external Skin protectant Fever blister (topical) Defer IIIE 310.545(a)(18)(iv)(A) Miscellaneous external Skin protectant Insect bite/sting IIIE IIIE 310.545(a)(18)(v) Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer IIIE 310.545(a)(18)(vi)(A)

Trolamine salicylate Miscellaneous external External analgesic Fever blister (topical) Defer IIIE 310.545(a)(10)(v) Miscellaneous external External analgesic Insect bite/sting n/a IIIE 310.545(a)(10)(vi) Miscellaneous external External analgesic Poison ivy/oak/

sumac n/a IIIE 310.545(a)(10)(vii)

Topical analgesic External analgesic Analgesic/anesthetic IIIE IIIE Pending Topical analgesic Sunscreen Sunscreen I I 352.10(q) Tryptophan Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20)

Review Panel Report Drug Category ANPR PR FR

Turpentine oil Cough/cold Cough/cold

(antitussive) Antitussive (oral) IISE IISE Pending

Cough/cold Cough/cold (antitussive)

Antitussive (topical/inhalant)

IIIE IIIE [52 FR 30055]

Cough/cold Cough/cold (expectorant)

Expectorant (topical/inhalant)

IIIE IIIE 310.545(a)(6)(iii)

Cough/cold Cough/cold (expectorant)

Expectorant (oral) IISE IISE 310.545(a)(6)(iii)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (oral)

IISE IISE 310.545(a)(6)(ii)(A)

Cough/cold Cough/cold (nasal decongestant)

Nasal decongestant (topical/inhalant)

IIIE IIIE 310.545(a)(6)(ii)(A)

Topical analgesic External analgesic Counterirritant I I Pending Miscellaneous external External analgesic Fever blister (topical) Defer IIIE 310.545(a)(10)(v) Miscellaneous external External analgesic Insect bite/sting IISE IISE 310.545(a)(10)(vi) Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IISE 310.545(a)(10)(vii)

Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(18)(v)(A) Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer IISE 310.545(a)(18)(vi)(A)

Turpentine oil, rectified Hemorrhoidal Anorectal Counterirritant

(intrarectal) IISE IISE 310.545(a)(26)(iv)

Hemorrhoidal Anorectal Counterirritant (external)

IISE IISE 310.545(a)(26)(iv)

Turpentine, venice Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Tyrosine Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Undecoylilum chlorideiodine complex [see

undecoyliumchloride iodine complex] ==== ==== ==== ==== ==== ==== Undecoylium chlorideiodine complex Antimicrobial I Antimicrobial Antimicrobial soap n/a IISE Pending Antimicrobial I Antimicrobial Skin wound cleanser IIISE IIISE Pending Antimicrobial I Antimicrobial Surgical hand scrub IIISE IIISE Pending Antimicrobial I Antimicrobial Skin protectant IIISE IIISE Pending Antimicrobial I Antimicrobial Skin antiseptic IIISE IIISE Pending Antimicrobial I Antimicrobial Preoperative skin prep IIISE IIISE Pending Antimicrobial I Antimicrobial Health care personnel

handwash IIIE IIIE Pending

Undecylenic acid Antimicrobial II Antifungal Antifungal I I 333.210(f) Miscellaneous external Antifungal Diaper rash Defer IISE 310.545(a)(22)(i) Undecylenic acid monoethanolamine

sulfosuccinate sodium Miscellaneous external Dandruff/seborrheic

dermatitis/psoriasis Dandruff/seborrheic

dermatitis/ psoriasis

IIIE IIIE 310.545(a)(7)

Urea Miscellaneous external Hair growth/loss Hair grower n/a IIE 310.527(a) Miscellaneous external Ingrown toenail Ingrown toenail IISE IISE 310.538(a) Miscellaneous internal Menstrual/diuretic Diuretic n/a IISE 310.545(a)(24)(i) Uva ursi, extract Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Valine Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Vegetable Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Vegetable oil Miscellaneous external Hair growth/loss Hair grower IISE n/a 310.527(a) Vitamin A Contraceptive/vaginal Vaginal Minor irritations IIIE Withdraw n/a Hemorrhoidal Anorectal Wound healing agent

(external) IIIE IIIE 310.545(a)(26)(x)

Hemorrhoidal Anorectal Wound healing agent (intrarectal)

IIIE IIIE 310.545(a)(26)(x)

Review Panel Report Drug Category ANPR PR FR

Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer IIISE Pending Miscellaneous external Corn/callus remover Corn/callus remover IISE IISE [55 FR 33261] Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Vitamin A acetate Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Vitamin A palmitate Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Antimicrobial Diaper Rash Defer n/a Pending Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Vitamin B Miscellaneous external Hair growth/loss Hair grower n/a IIE 310.527(a) Vitamin D [see cholecalciferol] ==== ==== ==== ==== ==== ==== Vitamin D2 [see ergocalciferol] ==== ==== ==== ==== ==== ==== Vitamin E Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Hair growth/loss Hair grower IIE n/a 310.527(a) Miscellaneous external Skin protectant Diaper rash Defer Withdraw n/a Miscellaneous internal Leg muscle cramp Nocturnal leg muscle cramps n/a IIISE 310.546 Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Sedative Stimulant Stimulant IIE IIE [39 FR 6104] Vitamins Miscellaneous external Hair growth/loss Hair grower IISE n/a 310.527(a) Miscellaneous internal Aphrodisiac Aphrodisiac n/a IISE 310.528(a) Vitromersal Miscellaneous external Mercury First aid antiseptic n/a IISE 310.545(a)(27)(i) Miscellaneous external Mercury Antiseptic IISE IISE 310.545(a)(27)(i) Water and additives ==== Ophthalmic Emergency first aid eyewash n/a I Pending Water, purified ==== Ophthalmic Eyewash n/a n/a 349.20 Wax, candelilla Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Wax, carnauba Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Wax, white Ophthalmic Ophthalmic Emollient I I 349.14(b)(6) Wax, yellow Ophthalmic Ophthalmic Emollient n/a I 349.14(b)(7) Wheat germ Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Wheat germ glycerides Miscellaneous external External analgesic Fever blister (topical) Defer n/a n/a Miscellaneous external Skin protectant Fever blister (topical) Defer n/a n/a Wheat germ oil Miscellaneous external Hair growth/loss Hair grower IIE IIE 310.527(a) White ointment Ophthalmic Ophthalmic Emollient I I 349.14(b)(8) White petrolatum ==== Skin protectant Skin protectant n/a n/a 347.10(r) White pine Cough/cold Cough/cold (expectorant) Expectorant IIIE IIIE 310.545(a)(6)(iii) White pine extract, compound Cough/cold Cough/cold (expectorant) Expectorant IIIE IIIE 310.545(a)(6)(iii)

Review Panel Report Drug Category ANPR PR FR

White pine syrup, compound Cough/cold Cough/cold

(expectorant) Expectorant IIISE IIIE 310.545(a)(6)(iii)

White thyme oil [see thyme oil, white] ==== ==== ==== ==== ==== ==== Wintergreen oil [see methyl salicylate] ==== ==== ==== ==== ==== ==== Witch hazel Hemorrhoidal Anorectal Astringent (external) I I 346.18 (b) Hemorrhoidal Anorectal Astringent

(intrarectal) I I 346.18 (b)

Miscellaneous external External analgesic Astringent I n/a n/a Miscellaneous external Skin protectant Astringent I I 347.12(c) Witch hazel water [see hamamelis water of xi] ==== ==== ==== ==== ==== ==== Woodruff Miscellaneous internal Digestive aid Digestive aid

(intestinal distress) n/a n/a 310.545(a)(18)(ii)

Wool alcohols [see lanolin alcohols] ==== ==== ==== ==== ==== ==== Xanthan gum Miscellaneous internal Weight control Anorectic IIIE IISE 310.545(a)(20) Xylometazoline hydrochloride Cough/cold Cough/cold (nasal

decongestant) Nasal decongestant I I 341.20(b)(10)

Yeast Miscellaneous internal Weight control Anorectic IISE IISE 310.545(a)(20) Yeast cell derivative, live Hemorrhoidal Anorectal Wound healing agent

(external) IIISE IIISE 310.545(a)(26)(vii)

Hemorrhoidal Anorectal Wound healing agent (intrarectal)

IIISE IIISE 310.545(a)(26)(vii)

sumac Defer I 347.10(s)

Miscellaneous external External analgesic Poison ivy/oak/ sumac

Defer IISE Pending

Topical analgesic Skin protectant Wound healing agent IIIE IIIE 310.545(a)(18)(i)(A) Topical analgesic Skin protectant Skin protectant I I 347.10(s) Zinc caprylate Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(a)(22)(ii) Zinc carbonate ==== Skin protectant Diaper rash Defer IIISE 310.545(a)(18)(iii) ==== Skin protectant Poison ivy/oak/

sumac n/a I 347.10(t)

Topical analgesic Skin protectant Skin protectant I I 347.10(t) Zinc chloride Miscellaneous external Corn/callus remover Corn/callus remover IIIE IIIE [55 FR 33261] Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Oral cavity Oral health care Astringent I I Pending Zinc citrate ==== Gingivitis/plaque Antiplaque/gingivitis n/a IIIE Pending

Review Panel Report Drug Category ANPR PR FR

Zinc oxide ==== n/a Sunscreen n/a I 352.10(r) ==== Skin protectant Poison ivy/oak/

sumac n/a I 347.10(u)

Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Hemorrhoidal Anorectal Astringent (external) I I 346.18 (c) Hemorrhoidal Anorectal Astringent

(intrarectal) I I 346.18 (c)

Hemorrhoidal Anorectal Protectant (external) I I 346.14(b)(4) Hemorrhoidal Anorectal Protectant

(intrarectal) I I 346.14(b)(4)

Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Miscellaneous external Boil treatment Boil treatment IISE IISE 310.531(a) Miscellaneous external External analgesic Astringent IISE IISE Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external External analgesic Insect bite/sting IISE IISE 310.545(a)(10)(vi) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Diaper rash Defer I Pending Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(18)(v)(A) Miscellaneous external Skin protectant Protectant I I Pending Topical analgesic Skin protectant Skin protectant I I Pending Zinc phenolsulfonate Laxative Antidiarrheal Antidiarrheal IIE IIE 310.545(a)(3)(i) Laxative Antiemetic Antiemetic IIIE IIE [52 FR 15891] Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Zinc propionate Antimicrobial II Antifungal Antifungal IIIE IIIE 310.545(a)(22)(ii) Zinc pyrithione [see pyrithione zinc] ==== ==== ==== ==== ==== ==== Zinc stearate Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Miscellaneous external Antifungal Diaper rash Defer n/a 310.545(a)(22)(i) Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external External analgesic Diaper rash Defer n/a 310.545(a)(10)(iv) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Diaper rash Defer n/a Pending Miscellaneous external Antimicrobial Diaper rash Defer n/a Pending Zinc sulfate Contraceptive/vaginal Vaginal Astringent IIIE Withdraw n/a Miscellaneous external External analgesic Astringent IISE n/a Pending Miscellaneous external External analgesic Fever blister (topical) Defer IIISE 310.545(a)(10)(v) Miscellaneous external Skin protectant Astringent IISE IISE 310.545(a)(18)(ii) Miscellaneous external Skin protectant Fever blister (topical) Defer IIIE 310.545(a)(18)(iv) Miscellaneous internal Poison treatment Emetic n/a IISE 310.545(a)(16) Ophthalmic Ophthalmic Astringent I I 349.10 Zinc sulfide Antimicrobial II Acne Acne IIE IIE 310.545(a)(1) Zinc undecylenate Antimicrobial II Antifungal Antifungal I I 333.210(f) Zirconium oxide Miscellaneous external External analgesic Insect bite/sting IISE IISE 310.545(a)(10)(vi) Miscellaneous external Skin protectant Insect bite/sting IISE IISE 310.545(a)(10)(vi) Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer IISE 310.545(a)(18)(vi)(A)

Miscellaneous external External analgesic Poison ivy/oak/ sumac

n/a IISE 310.545(a)(10)(vii)

Miscellaneous external External analgesic Poison ivy/oak/ sumac

Defer IISE 310.545(a)(10)(vii)

Zyloxin Miscellaneous external External analgesic Poison ivy/oak/

sumac Defer IISE 310.545(a)(10)(vii)

Miscellaneous external Mercury First aid antiseptic IISE n/a 310.545(a)(27)(i) Miscellaneous external Skin protectant Poison ivy/oak/

sumac Defer IISE 310.545(a)(18)(vi)(A)

Appendix II Unproven Safety of OTC Ingredients (1) Topical acne drug products. Alcloxa Alkyl isoquinolinium bromide Aluminum chlorohydrex Aluminum hydroxide Benzocaine Benzoic acid Boric acid Calcium polysulfide Calcium thiosulfate Camphor Chloroxylenol Cloxyquin Coal tar Dibenzothiophene Estrone Magnesium aluminum silicate Magnesium sulfate Phenol Phenolate sodium Phenyl salicylate Povidone-iodine Pyrilamine maleate Resorcinol (as single ingredient) Resorcinol monoacetate (as single ingredient) Salicylic acid (over 2% up to 5%) Sodium borate Sodium thiosulfate Tetracaine hydrochloride Thymol Vitamin E Zinc oxide Zinc stearate Zinc sulfide (2) Anticaries drug products-(i) Approved as of May 7, 1991. Hydrogen fluoride Sodium carbonate Sodium monofluorophosphate (6% rinse) Sodium phosphate (ii) Approved as of October 7, 1996. Calcium sucrose phosphate Dicalcium phosphate dihydrate Disodium hydrogen phosphate1

Phosphoric acid Sodium dihydrogen phosphate Sodium dihydrogen phosphate monohydrate Sodium phosphate, dibasic anhydrous reagent (3) Antidiarrheal drug products-(i) Approved as of May 7, 1991. Aluminum hydroxide Atropine sulfate Calcium carbonate Carboxymethylcellulose sodium Glycine Homatropine methylbromide Hyoscyamine sulfate Lactobacillus acidophilus Lactobacillus bulgaricus Opium, powdered Opium tincture Paregoric Phenyl salicylate Scopolamine hydrobromide

Zinc phenolsulfonate (ii) Approved as of April 19, 2004; April 18, 2005, for products with annual sales less than $25,000. Attapulgite, activated Bismuth subnitrate Calcium hydroxide Calcium polycarbophil Charcoal (activated) Pectin Polycarbophil Potassium carbonate Rhubarb fluidextract (4) Antiperspirant drug products-(i) IngredientsApproved as of May 7, 1991. Alum, potassium Aluminum bromohydrate Aluminum chloride (alcoholic solutions) Aluminum chloride (aqueous solution) (aerosol only) Aluminum sulfate Aluminum sulfate, buffered (aerosol only) Sodium aluminum chlorohydroxy lactate (ii) Approved as of December 9, 2004; June 9, 2005, for products with annual sales less than $25,000. Aluminum sulfate buffered with sodium aluminum lactate (5) [Reserved] (6) Cold, cough, allergy, bronchodilator, and antiasthmatic drug products-(i) Antihistamine drug products-(A) Ingredients. Methapyrilene hydrochloride Methapyrilene fumarate Thenyldiamine hydrochloride (B) Ingredients. Phenyltoloxamine dihydrogen citrate Methapyrilene hydrochloride Methapyrilene fumarate Thenyldiamine hydrochloride (ii) Nasal decongestant drug products-(A) Approved as of May 7, 1991. Allyl isothiocyanate Camphor (lozenge) Creosote, beechwood (oral) Eucalyptol (lozenge) Eucalyptol (mouthwash) Eucalyptus oil (lozenge) Eucalyptus oil (mouthwash) Menthol (mouthwash) Peppermint oil (mouthwash) Thenyldiamine hydrochloride Thymol Thymol (lozenge) Thymol (mouthwash) Turpentine oil (B) Approved as of August 23, 1995. Bornyl acetate (topical) Cedar leaf oil (topical) Creosote, beechwood (topical) Ephedrine (oral) Ephedrine hydrochloride (oral) Ephedrine sulfate (oral) Racephedrine hydrochloride (oral/topical) (C) Approved as of April 11, 2007; October 11, 2007, for products with annual sales less than $25,000. Any ingredient(s) labeled with claims or directions for use for sinusitis or for relief of nasal congestion associated with sinusitis. (iii) Expectorant drug products. Ammonium chloride

Antimony potassium tartrate Beechwood creosote Benzoin preparations (compound tincture of benzoin, tincture of benzoin) Camphor Chloroform Eucalyptol/eucalyptus oil Horehound Iodides (calcium iodide anyhydrous, hydroidic acid syrup, iodized lime, potassium iodide) Ipecac Ipecac fluidextract Ipecac syrup Menthol/peppermint oil Pine tar preparations (extract white pine compound, pine tar, syrup of pine tar, compound white pine syrup, white pine) Potassium guaiacolsulfonate Sodium citrate Squill preparations (squill, squill extract) Terpin hydrate preparations (terpin hydrate, terpin hydrate elixir) Tolu preparations (tolu, tolu balsam, tolu balsam tincture) Turpentine oil (spirits of turpentine) (iv) Bronchodilator drug products-(A) Approved as of October 2, 1987. Aminophylline Belladonna alkaloids Euphorbia pilulifera Metaproterenol sulfate Methoxyphenamine hydrochloride Pseudoephedrine hydrochloride Pseudoephedrine sulfate Theophylline, anhydrous Theophylline calcium salicylate Theophylline sodium glycinate (B) Approved as of January 29, 1996. Any combination drug product containing theophylline (e.g., theophylline and ephedrine, or theophylline and ephedrine and phenobarbital). (C) Approved as of June 19, 1996. Any ingredient(s) in a pressurized metered-dose inhaler container. (D) Approved as of October 29, 2001. Any oral bronchodilator active ingredient (e.g., ephedrine, ephedrine hydrochloride, ephedrine sulfate, racephedrine hydrochloride, or any other ephedrine salt) in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient. (7) Dandruff/seborrheic dermatitis/psoriasis drug products. Alkyl isoquinolinium bromide Allantoin Benzalkonium chloride Benzethonium chloride Boric acid Calcium undecylenate Captan Chloroxylenol Colloidal oatmeal Cresol, saponated Ethohexadiol Eucalyptol Juniper tar Lauryl isoquinolinium bromide Menthol Mercury oleate Methylbenzethonium chloride Methyl salicylate

Phenol Phenolate sodium Pine tar Povidone-iodine Resorcinol Sodium borate Sodium salicylate Thymol Undecylenic acid (8) Digestive aid drug products-(i) Approved as of May 7, 1991. Bismuth sodium tartrate Calcium carbonate Cellulase Dehydrocholic acid Dihydroxyaluminum sodium carbonate Duodenal substance Garlic, dehydrated Glutamic acid hydrochloride Hemicellulase Homatropine methylbromide Magnesium hydroxide Magnesium trisilicate Ox bile extract Pancreatin Pancrelipase Papain Peppermint oil Pepsin Sodium bicarbonate Sodium citrate Sorbitol (ii) Approved as of November 10, 1993. Alcohol Aluminum hydroxide Amylase Anise seed Aromatic powder Asafetida Aspergillus oryza enzymes (except lactase enzyme derived from Aspergillus oryzae) Bacillus acidophilus Bean Belladonna alkaloids Belladonna leaves, powdered extract Betaine hydrochloride Bismuth subcarbonate Bismuth subgallate Black radish powder Blessed thistle (cnicus benedictus) Buckthorn Calcium gluconate Capsicum Capsicum, fluid extract of Carbon Cascara sagrada extract Catechu, tincture Catnip Chamomile flowers Charcoal, wood Chloroform Cinnamon oil Cinnamon tincture Citrus pectin Diastase Diastase malt

Dog grass Elecampane Ether Fennel acid Galega Ginger Glycine Hydrastis canadensis (golden seal) Hectorite Horsetail Huckleberry Hydrastis fluid extract Hydrochloric acid Iodine Iron ox bile Johnswort Juniper Kaolin, colloidal Knotgrass Lactic acid Lactose Lavender compound, tincture of Linden Lipase Lysine hydrochloride Mannitol Mycozyme Myrrh, fluid extract of Nettle Nickel-pectin Nux vomica extract Orthophosphoric acid Papaya, natural Pectin Peppermint Peppermint spirit Phenacetin Potassium bicarbonate Potassium carbonate Protease Prolase Rhubarb fluid extract Senna Sodium chloride Sodium salicylate Stem bromelain Strawberry Strychnine Tannic acid Trillium Woodruff (iii) Charcoal, activated (9) [Reserved] (10) External analgesic drug products-(i) Analgesic and anesthetic drug products. Aspirin Chloral hydrate Chlorobutanol Cyclomethycaine sulfate Eugenol Hexylresorcinol Methapyrilene hydrochloride Salicylamide Thymol (ii) Counterirritant drug products. Chloral hydrate

Eucalyptus oil (iii) Male genital desensitizer drug products. Benzyl alcohol Camphorated metacresol Ephedrine hydrochloride (iv) Diaper rash drug products. Any ingredient(s) labeled with claims or directions for use in the treatment and/or prevention of diaper rash. (v) Fever blister and cold sore treatment drug products. Allyl isothiocyanate Aspirin Bismuth sodium tartrate Camphor (exceeding 3%) Capsaicin Capsicum Capsicum oleoresin Chloral hydrate Chlorobutanol Cyclomethycaine sulfate Eucalyptus oil Eugenol Glycol salicylate Hexylresorcinol Histamine dihydrochloride Menthol (exceeding 1%) Methapyrilene hydrochloride Methyl nicotinate Methyl salicylate Pectin Salicylamide Strong ammonia solution Tannic acid Thymol Tripelennamine hydrochloride Trolamine salicylate Turpentine oil Zinc sulfate (vi) Insect bite and sting drug products. Alcohol Alcohol, ethoxylated alkyl Benzalkonium chloride Calamine Ergot fluidextract Ferric chloride Panthenol Peppermint oil Pyrilamine maleate Sodium borate Trolamine salicylate Turpentine oil Zinc oxide Zirconium oxide (vii) Poison ivy, poison oak, and poison sumac drug products. Alcohol Aspirin Benzethonium chloride Benzocaine (0.5-1.25%) Bithionol Calamine Cetalkonium chloride Chloral hydrate Chlorobutanol Chlorpheniramine maleate Creosote, beechwood Cyclomethycaine sulfate Dexpanthenol

Diperodon hydrochloride Eucalyptus oil Eugenol Glycerin Glycol salicylate Hectorite Hexylresorcinol Hydrogen peroxide Impatiens biflora tincture Iron oxide Isopropyl alcohol Lanolin Lead acetate Merbromin Mercuric chloride Methapyrilene hydrochloride Panthenol Parethoxycaine hydrochloride Phenyltoloxamine dihydrogen citrate Povidone-vinylacetate copolymers Pyrilamine maleate Salicylamide Salicylic acid Simethicone Sulfur Tannic acid Thymol Trolamine salicylate Turpentine oil Zirconium oxide Zyloxin (11) [Reserved] (12) Laxative drug products-(i)(A) Bulk laxatives. Agar Carrageenan (degraded) Carrageenan (native) Guar gun (i)(B) Bulk laxatives-Approved as of March 29, 2007. Granular dosage forms containing psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago husks, or plantago seed including, but not limited to, any granules that are: (1 ) swallowed dry prior to drinking liquid; (2 ) dispersed, suspended, or partially dissolved in liquid prior to swallowing; (3 ) chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid; or (4 ) sprinkled over food. (ii) Saline laxative. Tartaric acid (iii) Stool softener. Poloxamer 188 (iv)(A) Stimulant laxatives-Approved as of May 7, 1991. Aloin Bile salts/acids Calcium pantothenate Calomel Colocynth Elaterin resin Frangula Gamboge Ipomea Jalap Ox bile Podophyllum resin Prune concentrate dehydrate

Prune powder Rhubarb, Chinese Sodium Oleate (iv)(B) Stimulant laxatives-Approved as of January 29, 1999. Danthron Phenolphthalein (C) Stimulant laxatives-Approved as of November 5, 2002. Aloe ingredients (aloe, aloe extract, aloe flower extract) Cascara sagrada ingredients (casanthranol, cascara fluidextract aromatic, cascara sagrada bark, cascara sagrada extract, cascara sagrada fluidextract). (13) [Reserved] (14) Oral health care drug products (nonantimicrobial). Antipyrine Camphor Cresol Dibucaine Dibucaine hydrochloride Eucalyptol Lidocaine Lidocaine hydrochloride Methly salicylate Myrrh tincture Pyrilamine maleate Sorbitol Sugars Tetracaine Tetracaine hydrochloride Thymol (15) Topical otic drug products-(i) For the prevention of swimmer’s ear and for the drying of water-clogged ears, approved as of May 7, 1991. Acetic acid (ii) For the prevention of swimmer’s ear, approved as of August 15, 1995. Glycerin and anhydrous glycerin Isopropyl alcohol (16) Poison treatment drug products. Ipecac fluidextract Ipecac tincture Zinc sulfate (17) Skin bleaching drug products. Mercury, ammoniated (18) Skin protectant drug products-(i)(A) IngredientsApproved as of May 7, 1991. Allantoin (wound healing claims only) Sulfur Tannic acid Zinc acetate (wound healing claims only) (B) Ingredients-Approved as of June 4, 2004; June 6, 2005, for products with annual sales less than $25,000. Beeswax Bismuth subnitrate Boric acid Cetyl alcohol Glyceryl stearate Isopropyl palmitate Live yeast cell derivative Shark liver oil Stearyl alcohol (ii) Astringent drug products. Acetone Alcohol Alum, ammonium Alum, potassium Aluminum chlorhydroxy complex

Aromatics Benzalkonium chloride Benzethonium chloride Benzocaine Benzoic acid Boric acid Calcium acetate Camphor gum Clove oil Colloidal oatmeal Cresol Cupric sulfate Eucalyptus oil Eugenol Ferric subsulfate (Monsel’s Solution) Honey Isopropyl alcohol Menthol Methyl salicylate Oxyquinoline sulfate p-t-Butyl-m-cresol Peppermint oil Phenol Polyoxeythylene laurate Potassium ferrocyanide Sage oil Silver nitrate Sodium borate Sodium diacetate Talc Tannic acid glycerite Thymol Topical starch Zinc chloride Zinc oxide Zinc phenolsulfonate Zinc stearate Zinc sulfate (iii) Diaper rash drug products. Aluminum hydroxide Cocoa butter Cysteine hydrochloride Glycerin Protein hydrolysate Racemethionine Sulfur Tannic acid Zinc acetate Zinc carbonate (iv) Fever blister and cold sore treatment drug products. Bismuth subnitrate Boric acid Pyridoxine hydrochloride Sulfur Tannic acid Topical starch Trolamine Zinc sulfate (v) Insect bite and sting drug products-(A) IngredientsApproved as of November 10, 1993. Alcohol Alcohol, ethoxylated alkyl Ammonia solution, strong Ammonium hydroxide Benzalkonium chloride

Camphor Ergot fluid extract Ferric chloride Menthol Peppermint oil Phenol Pyrilamine maleate Sodium borate Trolamine Turpentine oil Zirconium oxide (B) Ingredients-Approved as of June 4, 2004; June 6, 2005, for products with annual sales less than $25,000. Beeswax Bismuth subnitrate Boric acid Cetyl alcohol Glyceryl stearate Isopropyl palmitate Live yeast cell derivative Shark liver oil Stearyl alcohol (vi) Poison ivy, poison oak, and poison sumac drug products-(A) Ingredients-Approved as of November 10, 1993. Alcohol Anion and cation exchange resins buffered Benzethonium chloride Benzocaine Benzyl alcohol Bismuth subnitrate Bithionol Boric acid Camphor Cetalkonium chloride Chloral hydrate Chlorpheniramine maleate Creosote Diperodon hydrochloride Diphenhydramine hydrochloride Eucalyptus oil Ferric chloride Glycerin Hectorite Hydrogen peroxide Impatiens biflora tincture Iron oxide Isopropyl alcohol Lanolin Lead acetate Lidocaine Menthol Merbromin Mercuric chloride Panthenol Parethoxycaine hydrochloride Phenol Phenyltoloxamine dihydrogen citrate Povidone-vinylacetate copolymers Salicylic acid Simethicone Tannic acid Topical starch Trolamine Turpentine oil Zirconium oxide

Zyloxin (B) Ingredients-Approved as of June 4, 2004; June 6, 2005, for products with annual sales less than $25,000. Beeswax Bismuth subnitrate Boric acid Cetyl alcohol Glyceryl stearate Isopropyl palmitate Live yeast cell derivative Shark liver oil Stearyl alcohol (19) [Reserved] (20) Weight control drug products. Alcohol Alfalfa Alginic acid Anise oil Arginine Ascorbic acid Bearberry Biotin Bone marrow, red Buchu Buchu, potassium extract Caffeine Caffeine citrate Calcium Calcium carbonate Calcium caseinate Calcium lactate Calcium pantothenate Carboxymethylcellulose sodium Carrageenan Cholecalcierol Choline Chondrus Citric acid Cnicus benedictus Copper Copper gluconate Corn oil Corn syrup Corn silk, potassium extract Cupric sulfate Cyanocobalamin (vitamin B12) Cystine Dextrose Docusate sodium Ergocalciferol Ferric ammonium citrate Ferric pyrophosphate Ferrous fumarate Ferrous gluconate Ferrous sulfate (iron) Flax seed Folic acid Fructose Guar gum Histidine Hydrastis canadensis Inositol Iodine Isoleucine Juniper, potassium extract Karaya gum

Kelp Lactose Lecithin Leucine Liver concentrate Lysine Lysine hydrochloride Magnesium Magnesium oxide Malt Maltodextrin Manganese citrate Mannitol Methionine Methylcellulose Mono-and di-glycerides Niacinamide Organic vegetables Pancreatin Pantothenic acid Papain Papaya enzymes Pepsin Phenacetin Phenylalanine Phosphorus Phytolacca Pineapple enzymes Plantago seed Potassium citrate Pyridoxine hydrochloride (vitamin B6) Riboflavin Rice polishings Saccharin Sea minerals Sesame seed Sodium Sodium bicarbonate Sodium caseinate Sodium chloride (salt) Soybean protein Soy meal Sucrose Thiamine hydrochloride (vitamin B1) Thiamine mononitrate (vitamin B1 mononitrate) Threonine Tricalcium phosphate Tryptophan Tyrosine Uva ursi, potassium extract Valine Vegetable Vitamin A Vitamin A acetate Vitamin A palmitate Vitamin E Wheat germ Xanthan gum Yeast (21) Ophthalmic drug products. (i) Ophthalmic anesthetic drug products. Antipyrine Piperocaine hydrochloride (ii) Ophthalmic anti-infective drug products. Boric acid Mild silver protein

Yellow mercuric oxide (iii) Ophthalmic astringent drug products. Infusion of rose petals (iv) Ophthalmic demulcent drug products. Polyethylene glycol 6000 (v) Ophthalmic vasoconstrictor drug products. Phenylephrine hydrochloride (less than 0.08%) (22) Topical antifungal drug products. (i) Diaper rash drug products. Any ingredient(s) labeled with claims or directions for use in the treatment and/or prevention of diaper rash. (ii) Ingredients. Alcloxa Alum, potassium Aluminum sulfate Amyltricresols, secondary Basic fuchsin Benzethonium chloride Benzoic acid Benzoxiquine Boric acid Camphor Candicidin Chlorothymol Coal tar Dichlorophen Menthol Methylparaben Oxyquinoline Oxyquinoline sulfate Phenol Phenolate sodium Phenyl salicylate Propionic acid Propylparaben Resorcinol Salicylic acid Sodium borate Sodium caprylate Sodium propionate Sulfur Tannic acid Thymol Tolindate Triacetin Zinc caprylate Zinc propionate (iii) Any ingredient(s) labeled with claims or directions for use on the scalp or on the nails. (iv) Ingredients. Camphorated metacresol Chloroxylenol m-cresol Nystatin (23) Internal analgesic drug products-(i) Approved as of November 10, 1993. Aminobenzoic acid Antipyrine Aspirin, aluminum Calcium salicylate Codeine Codeine phosphate Codeine sulfate Iodoantipyrine Lysine aspirin Methapyrilene fumarate Phenacetin

Pheniramine maleate Pyrilamine maleate Quinine Salsalate Sodium aminobenzoate (ii) Approved as of February 22, 1999. Any atropine ingredient Any ephedrine ingredient (24) Orally administered menstrual drug products-(i) Approved as of November 10, 1993. Alcohol Alfalfa leaves Aloes Asclepias tuberosa Asparagus Barosma Bearberry (extract of uva ursi) Bearberry fluidextract (extract of bearberry) Blessed thistle (cnicus benedictus) Buchu powdered extract (extract of buchu) Calcium lactate Calcium pantothenate Capsicum oleoresin Cascara fluidextract, aromatic (extract of cascara) Chlorprophenpyridamine maleate Cimicifuga racemosa Codeine Collinsonia (extract stone root) Corn silk Couch grass Dog grass extract Ethyl nitrite Ferric chloride Ferrous sulfate Gentiana lutea (gentian) Glycyrrhiza (licorice) Homatropine methylbromide Hydrangea, powdered extract (extract of hydrangea) Hydrastis canadensis (golden seal) Hyoscyamine sulfate Juniper oil (oil of juniper) Magnesium sulfate Methapyrilene hydrochloride Methenamine Methylene blue Natural estrogenic hormone Niacinamide Nutmeg oil (oil of nutmeg) Oil of erigeron Parsley Peppermint spirit Pepsin, essence Phenacetin Phenindamine tartrate Phenyl salicylate Piscidia erythrina Pipsissewa Potassium acetate Potassium nitrate Riboflavin Saw palmetto Senecio aureus Sodium benzoate Sodium nitrate Sucrose Sulferated oils of turpentine

Taraxacum officinale Theobromine sodium salicylate Theophylline Thiamine hydrochloride Triticum Turpentine, venice (venice turpertine) Urea (ii) Approved as of February 22, 1999. Any atropine ingredient Any ephedrine ingredient (25) Pediculicide drug products-(i) Approved as of November 10, 1993. Benzocaine Benzyl alcohol Benzyl benzoate Chlorophenothane (dichlorodiphenyl trichloroethane) Coconut oil soap, aqueous Copper oleate Docusate sodium Formic acid Isobornyl thiocyanoacetate Picrotoxin Propylene glycol Sabadilla alkaloids Sulfur, sublimed Thiocyanoacetate (ii) Approved as of June 14, 1994. The combination of pyrethrum extract (formerly named pyrethrins) and piperonyl butoxide in an aerosol dosage formulation. (26) Anorectal drug products-(i) Anticholinergic drug products. Atropine Belladonna extract (ii) Antiseptic drug products. Boric acid Boroglycerin Hydrastis Phenol Resorcinol Sodium salicylic acid phenolate (iii) Astringent drug products. Tannic acid (iv) Counterirritant drug products. Camphor (greater than 3-11%) Hydrastis Menthol (1.25-16%) Turpentine oil (rectified) (6-50%) (v) Keratolytic drug products. Precipitated sulfur Sublimed sulfur (vi) Local anesthetic drug products. Diperodon Phenacaine hydrochloride (vii) Other drug products. Collinsonia extract Escherichia coli vaccines Lappa extract Leptandra extract Live yeast cell derivative Mullein

(viii) Protectant drug products. Bismuth oxide Bismuth subcarbonate Bismuth subgallate Bismuth subnitrate Lanolin alcohols (ix) Vasoconstrictor drug products. Epinephrine undecylenate (x) Wound-healing drug products. Cholecalciferol Cod liver oil Live yeast cell derivative Peruvian balsam Shark liver oil Vitamin A (xi) Combination drug products. Any combination drug product containing hydrocortisone and pramoxine hydrochloride. (27) Topical antimicrobial drug products-(i) First aid antiseptic drug products . Ammoniated mercury Calomel (mercurous chloride) Merbromin (mercurochrome) Mercufenol chloride (ortho-chloromercuriphenol, orthohydroxyphenylmercuric chloride) Mercuric chloride (bichloride of mercury, mercury chloride) Mercuric oxide, yellow Mercuric salicylate Mercuric sulfide, red Mercury Mercury oleate Mercury sulfide Nitromersol Para-chloromercuriphenol Phenylmercuric nitrate Thimerosal Vitromersol Zyloxin (ii) Diaper rash drug products. Para-chloromercuriphenol Any other ingredient containing mercury (28) Vaginal contraceptive drug products-(i) Approved as of October 22, 1998. Dodecaethylene glycol monolaurate (polyethylene glycol 600 monolaurate) Laureth 10S Methoxypolyoxyethyleneglycol 550 laurate Phenylmercuric acetate Phenylmercuric nitrate Any other ingredient containing mercury (ii) Approved as of November 5, 2002. Octoxynol 9 (29) Sunscreen drug products. Diethanolamine methoxycinnamate Digalloyl trioleate Ethyl 4-[bis(hydroxypropyl)] aminobenzoate Glyceryl aminobenzoate Lawsone with dihydroxyacetone Red petrolatum