Label: SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID- 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 2%

  • Purpose

    Acne treatment

  • Use

    for the management of acne

  • Warnings

    For external use only

    When using this product

    • 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.
    • avoid contact with eyes. If contact occurs, flush thoroughly with water

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

  • Directions

    • Clean the skin thoroughly before applying this product.
    • Apply a thin layer to affected area once a day before bedtime.
    • If bothersome dryness or peeling occurs, reduce application to every other day.
    • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.
  • Inactive ingredients

    Water, Ethoxydiglycol, Ethylhexyl Palmitate, Cetyl Alcohol, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, PEG-8, Laureth-4, Dimethicone, Aloe Barbadensis Leaf Juice, Polysorbate 80, DEA-Cetyl Phosphate, Polyacrylamide, Propylene Glycol, Sodium Citrate, Bisabolol, C13-14 Isoparaffin, Xanthan Gum, Disodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben

    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

    © 2014 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

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

    CVS® Quality

    Money Back Guarantee

    V-13649

    PLEASE RECYCLE

    V-31490

    #987593

    FP409

    M050790

  • Principal Display Panel - Carbon Label

    SKIN+
    PHARMACY

    ADVANCED
    ACNE
    THERAPY

    OVERNIGHT
    SALICYLIC
    ACID
    LOTION
    with Microsponge    ®
    Technology

    Maximum Strength 2% Salicylic Acid

    • works overnight to help eliminate existing blemishes
    • helps prevent new breakouts from forming
    • contains anti-inflammatory Bisabolol & soothing Ale Vera to calm skin
    • fragrance- & oil-free formula

    DERMATOLOGIST TESTED

    exclusively at
    CVS/pharmacy

    Actual Size Product
    on Side Panel

    1 FL OZ (30 mL)

    Principal Display Panel - Carbon Label
  • Principal Display Panel - Tube Label

    SKIN+PHARMACY

    ADVANCED
    ACNE
    THERAPY

    OVERNIGHT
    SALICYLIC ACID LOTION
    with Microsponge    ® Technology

    Maximum Strength
    2% Salicylic Acid

    • works overnight to help eliminate existing blemishes
    • helps prevent new breakouts from forming
    • contains anti-inflammatory Bisabolol & soothing Aloe Vera to calm skin
    • fragrance- & oil-free formula

    DERMATOLOGIST TESTED

    exclusively at
    CVS/pharmacy

    1 FL OZ (30 mL)

    Principal Display Panel - Tube Label
  • INGREDIENTS AND APPEARANCE
    SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ) salicylic acid20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    LAURETH-4 (UNII: 6HQ855798J)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    1,2-PROPANEDIOL, 1-BENZOATE (UNII: K4K90ZQ89N)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-066-011 in 1 CARTON05/01/2014
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/01/2014
    Labeler - CVS Health (062312574)
    Registrant - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMCOL Health & Beauty Solutions, Inc. DBA872684803ANALYSIS(69842-066) , MANUFACTURE(69842-066) , LABEL(69842-066) , PACK(69842-066)
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