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 October 27, 2022

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  • PRINCIPAL DISPLAY PANEL

    50 mL NDC: 77924-002-01

    Front label of Malezia Benzoyl Peroxide Gel

    Back label for benzoyl peroxide gel

    50 mL NDC: 77924-002-01

    dosage and adminstration

    50 mL NDC: 77924-002-01

    Warning section

    50 mL NDC: 77924-002-01

    inactive ingredients

    50 mL NDC: 77924-002-01

    active ingredient

    50 mL NDC: 77924-002-01

    purpose

    50 mL NDC: 77924-002-01

    indications and usage

    50 mL NDC: 77924-002-01

    children warning

  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77924-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77924-002-0250000 mg in 1 TUBE; Type 0: Not a Combination Product12/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/21/2020
    Labeler - Malezia LLC (123312045)
    Establishment
    NameAddressID/FEIBusiness Operations
    Malezia LLC123312045label(77924-002) , manufacture(77924-002) , pack(77924-002)
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