Label: BENZOYL PEROXIDE - benzoyl peroxide gel

  • 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.

Drug Label Information

Updated August 29, 2012

If you are a consumer or patient please visit this version.

  • Active ingredient

    Benzoyl peroxide 5% Close
  • Purpose

    Acne treatment Close
  • Use

    For the treatment of acne Close
  • Warnings

    For external use only Close
  • Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide
    Close
  • 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.
    Close
  • 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
  • Directions

    • 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.
    Close
  • 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
  • Questions?

    1-855-899-4237 Close
  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE  
    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)
    Close