Label: ACNE VANISHING GEL-10%- 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 January 23, 2020

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  • ACTIVE INGREDIENT

    10 % Benzoyl peroxide

  • PURPOSE

    To help with the control of acne

  • DOSAGE & ADMINISTRATION

    • Cleanse skin thoroughly before applying
    • Cover entire affected area with thin layer 1 to 3 times daily
    • If excessive dryness or irritation occurs, reduce application to once a day or every ther day
    • If going outside, use a sunscreen
  • WARNINGS

    WARNING: For external use only

  • INACTIVE INGREDIENT

    Water, Glycerin, Propylene Glycol, Ethoxydiglycol, Cetyl Octanoate, Glyceryl, Stearate, PEG-100 Stearate, Cetearyl Alcohol, Ceteareth-20, Dimthicone, Polysorbate 20, Laureth-7, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Polyacrylamide C3-14 Isoparaffin, Potassium Sorbate, Triethanolamine, Disodium EDTA, Ethylhexylglycerin, Phenooxyethanol

  • INDICATIONS & USAGE

    Treats acne and helps prevent new acne blemishes from forming

    Kills acne bacteria

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center

  • OTHER SAFETY INFORMATION

    Store at room temperature

    Keep tightly closed

  • ASK DOCTOR

    Consult a doctor if excessive irritation occurs

  • DO NOT USE

    Do not use if

    • you have very sensitive skin
    • if you are sensitive to benzoyl peroxide
  • WHEN USING

    When using this product

    • avoid sun exposure and use sunscreen
    • using other acne medicatons at the same time may cause excessive dryness or irritation of the skin
    • may bleach hair and fabrics
    • do not use near eyes, lips and mouth
  • PRINCIPAL DISPLAY PANEL

    Acne Vanishing Gel 10%

  • INGREDIENTS AND APPEARANCE
    ACNE VANISHING GEL-10% 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70367-001-0130 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    2NDC:70367-001-04120 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/26/2014
    Labeler - Only Yourx Inc. (089207519)
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