Label: BENZOYL PEROXIDE liquid
- NDC Code(s): 45802-280-01, 45802-280-34
- Packager: Padagis Israel Pharmaceuticals Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 12, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
-
Warnings
For external use only
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.
-
Directions
- •
- shake well
- •
- Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
- •
- wet area to be cleansed
- •
- apply acne wash and gently massage area for 1-2 minutes
- •
- rinse thoroughly and pat dry
- •
- 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.
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
BENZOYL PEROXIDE
benzoyl peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45802-280 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) IMIDUREA (UNII: M629807ATL) WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) SODIUM HYDROXIDE (UNII: 55X04QC32I) LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45802-280-01 142 g in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2013 07/31/2026 2 NDC:45802-280-34 227 g in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2013 07/31/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 01/24/2013 07/31/2026 Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
