Label: ACNE CORRECTING CLEANSER- salicylic acid 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 02/13

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    SALICYLIC ACID 2%

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  • PURPOSE

    PURPOSE

    ACNE TREATMENT

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  • INDICATIONS & USAGE

    USES

    • TREATS ACNE
    • DRIES UP ACNE PIMPLES
    • HELPS PREVENT NEW ACNE PIMPLES
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  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

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  • DO NOT USE

    DO NOT USE

    • IF YOU HAVE VERY SENSITIVE SKIN
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  • STOP USE

    STOP USE AND ASK A DOCTOR IF TOO MUCH SKIN RRITATION OR SENSITIVITY DEVELOPS OR INCREASES.

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  • KEEP OUT OF REACH OF CHILDREN

    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

    DIRECTIONS

    • Squeeze a small amount into the palm of your hand and create a slight lather using cool or warm water.
    • Gently massage the lather over your face for approximately 30 seconds.
    • Avoid the delicate eye area. Rinse thoroughly.
    • Consult your physician before use.
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  • OTHER SAFETY INFORMATION

    Other Information

    Store at 15-30°C (59-86°F)

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  • INACTIVE INGREDIENT

    INGREDIENTS

    aqua (water), sodium C14-16 olefin sulfonate cocamidopropyl betaine , sodium lauroyl methyl isethionate, PEG-120 distearate, allantoin, panthenol, avena sativa (oat) kernel extract, angelica sinensis extract, glycerin, cocamidopropyl PG-dimonium, chloride phosphate, polyquaternium-10, menthol, lecithin, citric acid, butylene glycol, ethylhexylglycerin, disodium EDTA, phenoxyethanol, potassium sorbate, methylchloroisothiazolinone, methylisothiazolinone, fragrance

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  • INGREDIENTS AND APPEARANCE
    ACNE CORRECTING CLEANSER 
    salicylic acid gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54272-101
    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  
    SODIUM C14-16 OLEFIN SULFONATE  
    COCAMIDOPROPYL BETAINE  
    SODIUM LAUROYL 1-METHYL ISETHIONATE  
    PEG-120 METHYL GLUCOSE DIOLEATE  
    ALLANTOIN  
    PANTHENOL  
    OAT  
    ANGELICA SINENSIS WHOLE  
    GLYCERIN  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE  
    POLYQUATERNIUM-10 (400 CPS AT 2%)  
    MENTHOL  
    LECITHIN, SOYBEAN  
    ANHYDROUS CITRIC ACID  
    BUTYLENE GLYCOL  
    ETHYLHEXYLGLYCERIN  
    EDETATE DISODIUM  
    PHENOXYETHANOL  
    POTASSIUM SORBATE  
    METHYLCHLOROISOTHIAZOLINONE  
    METHYLISOTHIAZOLINONE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54272-101-12 60 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 02/21/2013
    Labeler - CEN BEAUTY LLC (078664118)
    Registrant - CEN BEAUTY LLC (078664118)
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