Label: CLEAR PROOF ACNE TREATMENT ACNE MEDICATION- 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 April 25, 2019

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

  • Active ingredient:

    Benzoyl Peroxide 5%

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  • Purpose

    Acne Medication

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  • Uses

    • for the management of acne
    • dries up acne pimples
    • helps prevent new acne pimples
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  • Warnings

    For external use only.

    Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation 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.

    Stop use and ask a doctor if

    irritation becomes severe

    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 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 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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  • Other information

    • store at 59° to 86° F
    • 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

    clearproof

    acne treatment gel

    acne medication
    5% benzoyl peroxide

    1 OZ. NET WT./28 g

    Mary Kay

    image of carton

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  • INGREDIENTS AND APPEARANCE
    CLEAR PROOF ACNE TREATMENT  ACNE MEDICATION
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51531-9071
    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 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Poloxamer 182 (UNII: JX0HIX6OAG)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Docusate Sodium (UNII: F05Q2T2JA0)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Echinacea Purpurea (UNII: QI7G114Y98)  
    Cucumber (UNII: YY7C30VXJT)  
    Horse Chestnut (UNII: 3C18L6RJAZ)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51531-9071-1 1 in 1 CARTON 08/16/2016
    1 28 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 06/15/2012
    Labeler - Mary Kay Inc. (049994452)
    Establishment
    Name Address ID/FEI Business Operations
    Kolmar Laboratories Inc. 001535103 manufacture(51531-9071)
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