Label: CLEAR PROOF ACNE SYSTEM- benzoyl peroxide and salicylic acid   

  • Label RSS
  • 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 03/14

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  • Clarifying Cleansing Gel

    Drug Facts

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  • Active ingredient

    Salicylic Acid (2% W/W)

    Purpose

    Acne Medication

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  • Uses

    • for the management of acne
    • reduces the number of blackheads and acne pimples
    • helps prevent new acne pimples
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  • Warnings

    For external use only

    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 contact with the eyes

    Stop use and ask a doctor if

    irritation or sensitivity develops or occurs

    Keep our of reach of children.

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

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  • Directions

    • cleanse skin thoroughly before applying medication
    • cover the entire affected area with a thin layer then rinse thoroughly 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
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  • Inactive ingredients

    arctium lappa root extract, butylene glycol, citric acid, cocamidopropyl betaine, cystoseira amentacea/caespitosa branchycarpa extract, disodium EDTA, DMDM hydantoin, epilobium angustifolium flower/leaf/stem extract, ethylparaben, glycerin, methylparben, phenoxyethanol, propylene glycol, propylparaben, sodium C14-16 olefin sulfonate, sodium chloride, triethanolamine, water

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  • Blemish Control Toner

    Drug Facts

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  • Active ingredient

    Salicylic Acid (2% W/W)

    Purpose

    Acne Medication

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  • Uses

    • for the management of acne
    • reduces the number of blackheads and acne pimples
    • helps prevent new acne pimples
    Close
  • Warnings

    For external use only

    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 contact with the eyes

    Stop use and ask a doctor if

    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.

    Close
  • Directions

    • cleanse 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
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  • Inactive ingredients

    alcohol denat., citric acid, diethylhexyl sodium sulfosuccinate, eucalyptus globulus leaf oil, menthol, propylene glycol, simethicone, water

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  • Acne Treatment Gel

    Drug Facts

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  • Active ingredient

    Benzoyl Peroxide 5%

    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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  • DOSAGE & ADMINISTRATION

    • cleanse 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° F to 86° F
    • expiration date on tube crimp
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  • Inactive ingredients

    aesculus hippocastanum (horse chestnut) seed extract, alcohol denat., 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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  • Oil-Free Moisturizer for Acne-Prone Skin
  • INGREDIENTS:

    Water/Eau, Glycerin, Cetearyl Ethylhexanoate, Butylene Glycol, Caprylic/Capric Triglyceride, Glyceryl Stearate, Dimethicone, Isostearyl Alcohol, Stearic Acid, Betaine, Niacinamide, PEG-100 Stearate, Cetyl Alcohol, Cucurbita Pepo (Pumpkin) Fruit Extract, Silybum Marianum Fruit Extract, Tocopheryl Acetate, Lactobacillus/Ganoderma Lucidum (Reishi) Extract/Lentinus Edodes (Truncated), PEG-4 Laurate, Triethanolamine, Xanthan Gum, Carbomer, Disodium EDTA, Iodopropynyl Butylcarbamate, Phenoxyethanol, Diazolidinyl Urea, Sodium Benzoate

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  • Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    CLEAR PROOF ACNE SYSTEM 
    benzoyl peroxide and salicylic acid kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51531-8977
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51531-8977-0 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 TUBE 28 g
    Part 2 1 BOTTLE 147 mL
    Part 3 1 TUBE 127 g
    Part 4 1 TUBE 88 mL
    Part 1 of 4
    CLEAR PROOF ACNE TREATMENT  ACNE MEDICATION
    benzoyl peroxide gel
    Product Information
    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  
    ALCOHOL  
    DENATONIUM BENZOATE  
    TERT-BUTYL ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    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 08/15/2013
    Part 2 of 4
    CLEAR PROOF BLEMISH CONTROL TONER  ACNE MEDICATION
    salicylic acid liquid
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    DENATONIUM BENZOATE  
    TERT-BUTYL ALCOHOL  
    PROPYLENE GLYCOL  
    CITRIC ACID MONOHYDRATE  
    DOCUSATE SODIUM  
    EUCALYPTUS OIL  
    MENTHOL  
    DIMETHICONE  
    SILICON DIOXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 147 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 08/15/2013
    Part 3 of 4
    CLEAR PROOF CLARIFYING CLEANSING GEL  ACNE MEDICATION
    salicylic acid gel
    Product Information
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM C14 OLEFIN SULFONATE  
    COCAMIDOPROPYL BETAINE  
    SODIUM CHLORIDE  
    TROLAMINE  
    EDETATE DISODIUM  
    PHENOXYETHANOL  
    BUTYLENE GLYCOL  
    CITRIC ACID MONOHYDRATE  
    PROPYLENE GLYCOL  
    METHYLPARABEN  
    ETHYLPARABEN  
    DMDM HYDANTOIN  
    ARCTIUM LAPPA ROOT  
    PROPYLPARABEN  
    GLYCERIN  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 127 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 08/15/2013
    Part 4 of 4
    CLEAR PROOF OIL-FREE MOISTURIZER FOR ACNE-PRONE SKIN 
    other skin care preparations
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER  
    INGR GLYCERIN  
    INGR CETEARYL ETHYLHEXANOATE  
    INGR BUTYLENE GLYCOL  
    INGR MEDIUM-CHAIN TRIGLYCERIDES  
    INGR GLYCERYL MONOSTEARATE  
    INGR DIMETHICONE  
    INGR BETAINE  
    INGR STEARIC ACID  
    INGR ISOSTEARYL ALCOHOL  
    INGR PEG-100 STEARATE  
    INGR NIACINAMIDE  
    INGR DIAZOLIDINYL UREA  
    INGR CETYL ALCOHOL  
    INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)  
    INGR EDETATE DISODIUM  
    INGR .ALPHA.-TOCOPHEROL ACETATE  
    INGR PEG-4 LAURATE  
    INGR TROLAMINE  
    INGR XANTHAN GUM  
    INGR PUMPKIN  
    INGR MILK THISTLE  
    INGR IODOPROPYNYL BUTYLCARBAMATE  
    INGR PHENOXYETHANOL  
    INGR SODIUM BENZOATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 88 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 08/15/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 08/15/2013
    Labeler - Mary Kay Inc. (103978839)
    Establishment
    Name Address ID/FEI Business Operations
    Mary Kay Inc. 103978839 manufacture(51531-8977)
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