Label: ACNE VANISHING GEL- 5%- 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

    Benzoyl Peroxide 5%

  • INACTIVE INGREDIENT

    Water, Carbomer, Glycerin, Propylene Glycol, Ethoxydigiycol, Laureth-7, Polyacrylamide C13-14 Isoparaffin, Potassium Sorbate, Triethanolamine, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol

  • PURPOSE

    Acne Medication

  • INDICATIONS & USAGE

    treats acne and helps prevent new acne blemishes from forming

    kills acne bacteria

  • DOSAGE & ADMINISTRATION

    Directions:

    • Cleanse skin thoroughy 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 other day
    • If going outside, use a sunscreen
  • KEEP OUT OF REACH OF CHILDREN

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

  • WARNINGS

    WARNINGS: For External Use Only

  • OTHER SAFETY INFORMATION

    Other Information

    • Store at room temperature
    • Keep tightly closed
  • 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 medications at the same time may cause excessive dryness or irritation of the skin
    • may bleach hair and fabrics
    • do not use in or near eyes, lips and mouth
  • ASK DOCTOR

    Consult a doctor if excessive irritation occurs

  • PRINCIPAL DISPLAY PANEL

    Acne Vanishing Gel 5% Label

  • INGREDIENTS AND APPEARANCE
    ACNE VANISHING GEL- 5% 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70367-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LAURETH-7 (UNII: Z95S6G8201)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70367-002-0130 mL in 1 TUBE; Type 0: Not a Combination Product08/26/2014
    2NDC:70367-002-04120 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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