Label: BENZOYL PEROXIDE- benzoyl peroxide gel
- NDC Code(s): 45802-216-01, 45802-216-96
- Packager: Perrigo New York Inc
- 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 June 17, 2016
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- Active ingredient
Benzoyl peroxide 5%Close
for the treatment of acneClose
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.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- 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.
- 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 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.
- Other information
- store at 20°-25°C (68°-77°F)
- Inactive ingredients
carbomer homopolymer, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, sodium hydroxideClose
- Questions or comments?
- Package/Label Principal Display Panel
Benzoyl Peroxide 5%
Aqueous Base, Acne Treatment Gel
NET WT 2.1 OZ (60 g)Close
- INGREDIENTS AND APPEARANCE
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45802-216 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 DIMETHICONE (UNII: 92RU3N3Y1O) DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLOXAMER 182 (UNII: JX0HIX6OAG) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45802-216-01 1 in 1 CARTON 04/06/2012 1 90 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:45802-216-96 1 in 1 CARTON 03/13/2012 2 60 g 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 final part333D 03/13/2012 Labeler - Perrigo New York Inc (078846912)