Label: BENZOYL PEROXIDE 5% GEL- benzoyl peroxide gel

  • NDC Code(s): 68723-305-02
  • Packager: Axia Medical Solutions, LLC
  • 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 July 18, 2017

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

  • Active Ingredient:

    Benzoyl Peroxide 5%

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  • Purpose

    Acne Treatment

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  • USES:

    For the treatment of acne.

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  • WARNINGS:

    For external use only.

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  • Do not use if you:

    • Have sensitive skin. • Are sensitive to benzoyl peroxide.

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  • When using the product:

    • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If this occurs only use one topical acne medication at a time • Avoid unnecessary sun exposure and use a sunscreen • Avoid contact with the eyes, lips, and mouth • Avoid contact with hair and dyed fabrics which may be bleached by this product • Skin irritation may occur characterized by redness, burning, itching, peeling, or possibly swelling.  Irritation may be reduced by using the product less frequently or in a lower concentration.

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  • Stop use and ask a doctor if:

    Irritation become severe.

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  • Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

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  • DIRECTIONS:

    • Clean the skin thoroughly before applying this product • Cover the entire affected area with a thin layer one to three times daily • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor • If bothersome dryness or peeling occurs, reduce application to once a day or every other day • If going outside, apply sunscreen after using this product.  If irritation or sensitivity develops, stop use of both products and ask a doctor.

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  • Inactive Ingredients:

    Allantoin, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Disodium Laureth Sulfosuccinate, Glycerin, Panthenol, PEG-8, PEG-14 Palmeth-60 Hexyl Dicarbamate, Sodium Hyaluronate, Triethanolamine, and Water.

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  • OTHER INFORMATION:

    • Store at controlled room temperature 15-30°C (59-86°F)

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  • Questions?:

    866-494-4466, Mon-Fri 8:00AM-5:00PM

    Dist. By Axia Medical Solutions, 2105 Camino Vida Roble, Carlsbad, Ca. 92011

    www.dermesse.com     866-494-4466 office, 760-931-8267 fax

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  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 5% GEL 
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68723-305
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg  in 1000 mg
    Inactive Ingredients
    Ingredient Name Strength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PPG-14 PALMETH-60 HEXYL DICARBAMATE (UNII: 376C96Y6AL)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68723-305-02 57 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/18/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 07/18/2017
    Labeler - Axia Medical Solutions, LLC (929224694)
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