Label: BLEMISH CORRECTING SERUM SENSITIVE- 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
    • ARE SENSITIVE TO BENZOYL PEROXIDE
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  • WHEN USING

    WHEN USING 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.
    • 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.
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  • STOP USE

    STOP USE AND ASK A DOCTOR IF TOO MUCH SKIN IRRITATION 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

    • ON CLEAN AND DRY SKIN, APPLY A SMALL AMOUNT EVENLY OVER THE AFFECTED AREAS.
    • AVOID THE DELICATE EYE AREA.
    • START WITH ONE APPLICATION DAILY THEN GRADUALLY INCREASE TO TWO 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.
    • CONSULT A PHYSICIAN BEFORE USE.
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  • OTHER SAFETY INFORMATION

    Other Information

    Store at 20-25 DEGREES CELCIUS (68-78 DEGREES FAHRENHEIT)

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  • INACTIVE INGREDIENT

    INGREDIENTS

    aqua (water), ethoxydiglycol, butylene glycol, glycereth-7 trimethyl ether, aminomethylpropanol, potassium azeloyl, diglycinate, syringa vulgaris (lilac) leaf cell culture extract, dipotassium glycyrrhizate, urea, angelica sinensis extract, avena sativa (oat) extract, avena sativa (oat) kernel extract, hamamelis virginiana (witch hazel) , bark/leaf/twig extract, papain, betaine, calcium pantothenate, proline, Alanine, serine, magnesium lactate, potassium lactate, lecithin, glycerin, maltodextrin , ethylhexylglycerin, sodium citrate, xanthan gum, hydroxyethylcellulose, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, magnesium chloride, benzyl alcohol , sorbic acid, caprylyl glycol, phenoxyethanol, ethylhexylglycerin

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  • INGREDIENTS AND APPEARANCE
    BLEMISH CORRECTING SERUM  SENSITIVE
    salicylic acid gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54272-103
    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  
    DIETHYLENE GLYCOL MONOETHYL ETHER  
    BUTYLENE GLYCOL  
    GLYCERETH-7 TRIMETHYL ETHER  
    AMINOMETHYLPROPANOL  
    POTASSIUM AZELOYL DIGLYCINATE  
    SYRINGA VULGARIS WHOLE  
    GLYCYRRHIZINATE DIPOTASSIUM  
    UREA  
    ANGELICA SINENSIS WHOLE  
    AVENA SATIVA TOP  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK  
    PAPAIN  
    BETAINE  
    CALCIUM PANTOTHENATE  
    PROLINE  
    ALANINE  
    SERINE  
    MAGNESIUM LACTATE  
    POTASSIUM LACTATE  
    LECITHIN, SOYBEAN  
    GLYCERIN  
    MALTODEXTRIN  
    ETHYLHEXYLGLYCERIN  
    SODIUM CITRATE  
    XANTHAN GUM  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    EDETATE DISODIUM  
    MAGNESIUM CHLORIDE  
    BENZYL ALCOHOL  
    SORBIC ACID  
    CAPRYLYL GLYCOL  
    PHENOXYETHANOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54272-103-11 30 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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