Label: ACNE VANISHING GEL- 5%- benzoyl peroxide gel

  • NDC Code(s): 70367-002-01, 70367-002-04
  • Packager: Only Yourx, Inc.
  • 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 August 8, 2018

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

  • ACTIVE INGREDIENT

    Benzoyl Peroxide 5%

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  • INACTIVE INGREDIENT

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

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  • PURPOSE

    Acne Medication

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  • INDICATIONS & USAGE

    treats acne and helps prevent new acne blemishes from forming

    kills acne bacteria

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  • 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
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  • KEEP OUT OF REACH OF CHILDREN

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

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  • WARNINGS

    WARNINGS: For External Use Only

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  • OTHER SAFETY INFORMATION

    Other Information

    • Store at room temperature
    • Keep tightly closed
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  • DO NOT USE

    Do not use

    • If you have very sensitive skin
    • If you are sensitive to benzoyl peroxide
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  • 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
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  • ASK DOCTOR

    Consult a doctor if excessive irritation occurs

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  • INGREDIENTS AND APPEARANCE
    ACNE VANISHING GEL- 5% 
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70367-002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70367-002-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2014
    2 NDC:70367-002-04 120 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2014
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 08/26/2014
    Labeler - Only Yourx, Inc. (089207519)
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