Label: BENZOYL PEROXIDE gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 30, 2024

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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 DrugM00608/21/2020
    Labeler - Malezia LLC (123312045)
    Establishment
    NameAddressID/FEIBusiness Operations
    Malezia LLC123312045label(77924-002) , manufacture(77924-002) , pack(77924-002)
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