Label: BENZOYL PEROXIDE - benzoyl peroxide gel
- NDC Code(s): 24470-909-60
- Packager: Cintex Services, 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 August 29, 2012
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- Active ingredient
Benzoyl peroxide 5% Close
Acne treatment Close
For the treatment of acne Close
For external use only Close
- Do not use if you
- have very sensitive skin
- are sensitive to benzoyl peroxide
- 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.
- STOP USE
Stop use and ask a doctor if irritation becomes severe. Close
- KEEP OUT OF REACH OF CHILDREN
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center immediately. Close
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer and rinse thoroughly 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 15°-30°C (59°-86°F). Close
- Inactive ingredients
allantoin, aloe barbadensis leaf extract, benzyl alcohol, carbomer, disodium EDTA, disodium laureth sulfosuccinate, glycerin, panthenol, PEG-8, PPG-14 palmeth-60 hexyl dicarbamate, sodium hyaluronate, triethanolamine, water Close
- INGREDIENTS AND APPEARANCE
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24470-909 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 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC) 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) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24470-909-60 60 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/28/2012 Labeler - Cintex Services, LLC (078304114)