Label: ACNE CORRECTING CLEANSER- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL

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 February 23, 2013

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    SALICYLIC ACID 2%

  • PURPOSE

    PURPOSE

    ACNE TREATMENT

  • INDICATIONS & USAGE

    USES

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

    WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    DO NOT USE

    • IF YOU HAVE VERY SENSITIVE SKIN
  • WHEN USING

  • STOP USE

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

  • 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.

  • 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.
  • OTHER SAFETY INFORMATION

    Other Information

    Store at 15-30°C (59-86°F)

  • 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

  • PRINCIPAL DISPLAY PANEL

    BB_Acne Correcting Cleanser-SA_2oz_Tubes_ARTWORK_FR

    BB_Acne Correcting Cleanser-SA CX870S 20130223

  • INGREDIENTS AND APPEARANCE
    ACNE CORRECTING CLEANSER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54272-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAUROYL 1-METHYL ISETHIONATE (UNII: 8D813TG5U5)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    OAT (UNII: Z6J799EAJK)  
    ANGELICA SINENSIS WHOLE (UNII: 697D19QDBN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    MENTHOL (UNII: L7T10EIP3A)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54272-101-1260 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/21/2013
    Labeler - CEN BEAUTY LLC (078664118)
    Registrant - CEN BEAUTY LLC (078664118)
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