Label: BENZOYL PEROXIDE 5% GEL- benzoyl peroxide gel
- NDC Code(s): 68723-305-02
- Packager: Axia Medical Solutions, LLC
- 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.
Updated January 24, 2020
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- Active Ingredient:
- Do not use if you:
When using the product:
• Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If this 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:
- Keep out of reach of children.
• Clean the skin thoroughly before applying this product • Cover the entire affected area with a thin layer one to three times daily • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to 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.
- Inactive Ingredients:
- OTHER INFORMATION:
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
BENZOYL PEROXIDE 5% GEL
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68723-305 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1000 mg Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) EDETATE DISODIUM (UNII: 7FLD91C86K) 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:68723-305-02 57 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/18/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/18/2017 Labeler - Axia Medical Solutions, LLC (929224694)