Label: BENZOYL PEROXIDE gel
- NDC Code(s): 71800-043-04
- Packager: Innovida Pharmaeutique Corporation
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 25, 2025
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
When using this productkeep away from eyes, lips and mouth
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor.
• using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water. - KEEP OUT OF REACH OF CHILDREN
- Directions
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- Inactive Ingredients
- Product label
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INGREDIENTS AND APPEARANCE
BENZOYL PEROXIDE
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71800-043 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 1 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) EDETATE DISODIUM (UNII: 7FLD91C86K) LAURETH-4 (UNII: 6HQ855798J) SODIUM HYDROXIDE (UNII: 55X04QC32I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71800-043-04 1 in 1 CARTON 02/10/2025 1 44 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 02/10/2025 Labeler - Innovida Pharmaeutique Corporation (080892908)