Label: CLEAR BLEMISH TREATMENT JAFRA- salicylic acid gel

  • NDC Code(s): 68828-129-01, 68828-129-02
  • Packager: JAFRA COSMETICS INTERNATIONAL
  • 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 03/13

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Salicylic Acid 2% Acne treatment Gel

    Uses

    treats acne

    dries up acne pimples

    helps prevent new acne pimples

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

    When using this product

    using other topical acne medication at the same time or immediately following the 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.

    Warnings

    For external use only

    Directions

    Clean the skin thoroughly before applying.

    Cover the entire affected area with a thin layer 1 to 3 times daily.

    Avoid contact with eyes

    Because excessive drying of the skin may occur start with 1 application daily, then gradually increase to 2 or 3 times daily.

    If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

    Inactive Ingredients: Acrylates/C10-30 Alkyl acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Denatonium Benzoate, Disodium Phosphate, Ethoxydiglycol, Eugenia Caryophyllus (clove) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Melia Azadirachta Extract, Panthenol, PPG-5 Ceteth-20, Propylene Glycol, Saccharide Isomerate, Salvia Sclarea (Clary) Oil, SD Alcohol 40-B/Alcohol Denat, Colloidal Sulfur, Water/Aqua, Xanthan Gum, Yeast Extract.

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  • PRINCIPAL DISPLAY PANEL

    back

    front

    Clear Blemish Treatment

    Gel Facial De Control Expecializado

    15 ml .5 Fl Oz US

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  • INGREDIENTS AND APPEARANCE
    CLEAR BLEMISH TREATMENT  JAFRA
    salicylic acid gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68828-129
    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 151 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    ALOE VERA LEAF  
    DENATONIUM BENZOATE  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    DIETHYLENE GLYCOL MONOETHYL ETHER  
    CLOVE LEAF OIL  
    LAVENDER OIL  
    AZADIRACHTA INDICA BARK  
    PANTHENOL  
    PPG-5-CETETH-20  
    PROPYLENE GLYCOL  
    SACCHARIDE ISOMERATE  
    CLARY SAGE OIL  
    XANTHAN GUM  
    YEAST  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68828-129-02 1 in 1 BOX
    1 NDC:68828-129-01 15 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 06/19/2012
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    Name Address ID/FEI Business Operations
    Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-129)
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