Label: SKINPHARMACY ADVANCED ACNE THERAPY PORE REFINING FACIAL MASK- salicylic acid liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 March 14, 2017

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  • Active Ingredient

    Salicylic Acid 0.5%

  • Purpose

    Acne

  • Use

    for the management of acne

  • Warnings

    For external use only

    When using this product

    • using other topical acne medications at the same time or immediately following 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.
    • avoid contact with eye. if contact occurs, flush thoroughly with water.
    • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

    Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Once to twice per week, apply a generous layer evenly onto cleansed skin avoiding the eye area.
    • Leave on for 10 minutes.
    • Rinse thoroughly with water.
    • Follow with your favorite Skin+Pharmacy moisturizer.
  • Inactive ingredients

    Water, Kaolin, Glycerin, Bentonite, Butylene Glycol, Cetearyl Alcohol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cocamidopropyl Betaine, PEG-100 Stearate, Magnesium Aluminum Silicate, Glyceryl Stearate, Phenoxyethanol, Ceteareth-20, Xanthan Gum, Chlorphenesin, Caffeine, Ethylhexylglycerin, Disodium EDTA, Citric Acid, Sodium Hydroxide, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Bisabolol.

    Microsponge® is a registered trademark of AMCOL International Corp.

    Save carton for complete labeling since all warnings are not included on the inner package.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2016 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    Made in the U.S.A. of U.S. and foreign components

    V-13649

    CVS® Quality

    Money Back Guarantee

    M050873CP

    FP419

    #742825

  • Principal Display Panel - Carton Label

    SKIN+
    PHARMACY

    ADVANCED
    ACNE
    THERAPY

    PORE REFINING
    FACIAL MASK
    with Microsponge    ®
    Technology

    0.5% Salicylic Acid

    • contains anti-inflammatory Bisabolol & Vitamins A & E
    • helps eliminate & prevent blemishes
    • unclogs pores
    • fragrance & oil-free formula

    DERMATOLOGIST TESTED

    exclusively at
    CVS/pharmacy

    Actual Product Size
    on Side Panel

    3.3 FL OZ (99 mL)

    Principal Display Panel - Carton Label
  • Principal Display Panel - Tube Label

    SKIN+
    PHARMACY

    ADVANCED
    ACNE
    THERAPY

    PORE REFINING
    FACIAL MASK
    with Microsponge    ®
    Technology

    0.5% Salicylic Acid

    • contains anti-inflammatory Bisabolol & Vitamins A & E
    • helps eliminate & prevent blemishes
    • unclogs pores
    • fragrance & oil-free formula

    DERMATOLOGIST TESTED

    exclusively at
    CVS/pharmacy

    3.3 FL OZ (99 mL)

    Principal Display Panel - Tube Label
  • INGREDIENTS AND APPEARANCE
    SKINPHARMACY ADVANCED ACNE THERAPY PORE REFINING FACIAL MASK 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ) salicylic acid5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    kaolin (UNII: 24H4NWX5CO)  
    glycerin (UNII: PDC6A3C0OX)  
    bentonite (UNII: A3N5ZCN45C)  
    butylene glycol (UNII: 3XUS85K0RA)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)  
    cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    peg-100 stearate (UNII: YD01N1999R)  
    magnesium aluminum silicate (UNII: 6M3P64V0NC)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    xanthan gum (UNII: TTV12P4NEE)  
    chlorphenesin (UNII: I670DAL4SZ)  
    caffeine (UNII: 3G6A5W338E)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    edetate disodium (UNII: 7FLD91C86K)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    sodium hydroxide (UNII: 55X04QC32I)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    levomenol (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-077-011 in 1 CARTON07/01/2016
    199 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2016
    Labeler - CVS Health (062312574)
    Registrant - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMCOL Health & Beauty Solutions, Inc. DBA872684803ANALYSIS(69842-077) , MANUFACTURE(69842-077) , LABEL(69842-077) , PACK(69842-077)
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