Label: MARY KAY ACNE TREATMENT ACNE MEDICATION- benzoyl peroxide gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • Active ingredient:


    Benzoyl Peroxide 5%
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  • Purpose


    Acne Medication
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  • Uses


    • treats acne
    • dries up acne pimples
    • helps prevent new acne pimples
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  • Warnings

    For external use only.

    Do not use this product if

    • you have very sensitive skin
    • you are sensitive to benzoyl peroxide
    • on large areas of the body

    When using this product

    • avoid unnecessary sun exposure and use sunscreen
    • avoid eyes, lips and mouth
    • this product may bleach hair or dyed fabrics
    • this product may cause irritation
    • using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    Stop use and ask a doctor if

    too much skin irritation or sensitivity develops or increases.

    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.
    • cover the entire affected area with a thin layer one to three times daily.
    • because too much drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily, if needed or as directed by a doctor.
    • if bothersome dryness or peeling occurs, reduce application to once a day or oevery other day.
    • if going outside, use a sunscreen. Allow benzoyl peroxide to dry, then follow directions in the sunscreen labeling.
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  • Other information


    • store at 59F to 86F
    • expiration date on tube crimp
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  • Inactive ingredients

    aesculus hippocastanum (horse chestnut) seed extract, butylene glycol, carbomer, cucumis sativus (cucumber) fruit extract, diethylhexyl sodium sulfosuccinate, disodium EDTA, echinacea purpurea extract, glycerin, poloxamer 182, propylene glycol, silica, sodium hydroxide, water.

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  • Principal Display Panel - 28 g carton


    Mary Kay
    acne treatment gel

    acne medication
    5% benzoyl peroxide

    1 OZ. NET WT./28 g

    Image of carton label

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  • INGREDIENTS AND APPEARANCE
    MARY KAY ACNE TREATMENT  ACNE MEDICATION
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51531-0813
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide 5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Propylene Glycol  
    Poloxamer 182  
    Silicon Dioxide  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)  
    Sodium Hydroxide  
    Docusate Sodium  
    Edetate Disodium  
    Glycerin  
    Butylene Glycol  
    Echinacea Purpurea  
    Cucumber  
    Horse Chestnut  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51531-0813-1 1 in 1 CARTON
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/19/1988
    Labeler - Mary Kay Inc. (103978839)
    Establishment
    Name Address ID/FEI Business Operations
    Kolmar Laboratories Inc. 001535103 manufacture(51531-0813)
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