Label: 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 December 26, 2019

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

  • Active ingredient

    Benzoyl peroxide 5%

  • Purpose

    Acne treatment

  • Use

    For the treatment of acne

  • Warnings

    For external use only

  • 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.

  • 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.

  • 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.
  • Other information

    Store at 15°-30°C (59°-86°F).

  • 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

  • Questions?

    1-855-899-4237

  • PRINCIPAL DISPLAY PANEL

    label
  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24470-909
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24470-909-6060 g in 1 BOTTLE; Type 0: Not a Combination Product06/28/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/28/2012
    Labeler - Cintex Services, LLC (078304114)