Label: SKINPHARMACY ADVANCED ACNE THERAPY SPOT TREATMENT- benzoyl peroxide 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 28, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 5%

  • Purpose

    Acne Treatment

  • Use

    • for the management of acne
  • Warnings

    For external use only

    Do not this medication if you

    • Have very sensitive skin
    • Are sensitive to benzoyl peroxide

    When using this product

    • Avoid unnecessary sun exposure and use a sunscreen.
    • Avoid contact with lips, eyes, or mouth. If product gets into the rinse thoroughly with water.
    • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling. Irritation may be reduced by using the product less frequently or in lower concentration.
    • Avoid contact with hair and dyed fabrics, which may be bleached by this product.

    Stop use and ask a doctor if irritation becomes severe.

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

  • Directions

    • Clean skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily.
    • If going outside apply sunscreen after using this product. If irritation occurs, stop using both products and consult a physician.
    • Keep tightly closed Avoid storing at extreme temperature (below 40°F and above 100°F)
  • Inactive ingredients

    Water, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Sorbitol, Cetyl Alcohol, Glyceryl Dilaurate, Stearyl Alcohol, Magnesium Aluminum Silicate, Sodium Citrate, Silica, Sodium Lauryl Sulfate, Citric Acid, Methylparaben, Xanthan Gum, Propylparaben.

    Microsponge® is a registered trademark of AMCOL International Corp.

    Save carton for complete labeling

    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 imported components

    V-31490

    CVS® Quality

    Money Back Guarantee

    #971013

    M050738

    FP408

  • Principal Display Panel - Carton Label

    SKIN+
    PHARMACY

    ADVANCED
    ACNE
    THERAPY

    SPOT TREATMENT
    with Microsponge    ® Technology

    5% Benzoyl Peroxide

    • clinically proven
      to effectively reduce
      inflammatory lesions
    • effectively kills
      acne-causing bacteria
    • helps reduce irritation
    • fragrance free

    DERMATOLOGIST TESTED

    exclusively at
    CVS/pharmacy

    0.75 FL OZ (22 mL)

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

    SKIN+PHARMACY

    ADVANCED
    ACNE
    THERAPY

    SPOT TREATMENT
    with Microsponge    ® Technology

    5% Benzoyl Peroxide

    • clinically proven
      to effectively reduce
      inflammatory lesions
    • effectively kills
      acne-causing bacteria
    • helps reduce irritation
    • fragrance free

    DERMATOLOGIST TESTED

    exclusively at
    CVS/pharmacy

    0.75 FL OZ (22 mL)

    Principal Display Panel - Label
  • INGREDIENTS AND APPEARANCE
    SKINPHARMACY ADVANCED ACNE THERAPY SPOT TREATMENT 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzoyl peroxide (UNII: W9WZN9A0GM) (benzoyl peroxide - UNII:W9WZN9A0GM) benzoyl peroxide50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)  
    cetyl alcohol (UNII: 936JST6JCN)  
    sorbitol (UNII: 506T60A25R)  
    glyceryl dilaurate (UNII: MFL3ZIE8SK)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    magnesium aluminum silicate (UNII: 6M3P64V0NC)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    methylparaben (UNII: A2I8C7HI9T)  
    xanthan gum (UNII: TTV12P4NEE)  
    propylparaben (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-023-011 in 1 CARTON06/01/2014
    122 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/01/2014
    Labeler - CVS Health (062312574)
    Registrant - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMCOL Health & Beauty Solutions, Inc. DBA872684803MANUFACTURE(69842-023) , PACK(69842-023) , LABEL(69842-023) , ANALYSIS(69842-023)
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