Label: BENZOYL PEROXIDE gel
- NDC Code(s): 84339-001-01
- Packager: Enrich Enterprises Xiamen Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 20, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
-
WHEN USING
When using this product
- Avoid unnecessary sun exposure and use an SPF.
-Avoid contact with the eyes, lips, mouth and hair.
- Skin irritation, redness, burning, itching or peeling may occur.
- Only use one topical acne medication at a time as skin irritation and dryness is more likely to occur.
- Keep out of reach of children.
-If swallowed get medical help or call poison control center immediately.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BENZOYL PEROXIDE
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84339-001 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER 980 (UNII: 4Q93RCW27E) SODIUM HYDROXIDE (UNII: 55X04QC32I) PROPANEDIOL (UNII: 5965N8W85T) PHYTATE SODIUM (UNII: 88496G1ERL) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84339-001-01 1 in 1 BOX 05/20/2024 1 50 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 05/20/2024 Labeler - Enrich Enterprises Xiamen Limited (529499545) Establishment Name Address ID/FEI Business Operations Enrich Enterprises Xiamen Limited 529499545 manufacture(84339-001)