Label: L-TOPICAL BENZOYL PEROXIDE 10% GEL- benzoyl peroxide gel
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- NDC Code(s): 73921-032-04
- Packager: GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 29, 2021
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Warnings
For external use only
Do not use if you • Have very sensitive skin • Are sensitive to benzoyl peroxide
When using this product • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. • Avoid unnecessary sun exposure and use a sunscreen • Avoid contact with the eyes, lips, and mouth • Avoid contact with hair and dyed fabrics, which may be bleached by this product • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Stop use and ask a doctor if irritation becomes severe.
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Directions
• Clean the skin thoroughly before applying this product • Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor • If bothersome dryness or peeling occurs, reduce application to once a day or every other day. • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
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INGREDIENTS AND APPEARANCE
L-TOPICAL BENZOYL PEROXIDE 10% GEL
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73921-032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PPG-14 PALMETH-60 HEXYL DICARBAMATE (UNII: 376C96Y6AL) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73921-032-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 04/01/2021 Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917) Establishment Name Address ID/FEI Business Operations GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED 860186917 manufacture(73921-032)
