Label: SKINPHARMACY ADVANCED ACNE THERAPY ACTIVE CLEARING- 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 14, 2017

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 2.5%

  • Purpose

    Acne Treatment

  • Use

    • For the management of acne
  • Warnings

    For external use only

    Do not use 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 after using this product.
    • Avoid contact with lips, eyes, or mouth.
    • If product gets into the eyes 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.
    • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

    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.
    • Apply a thin layer to affected area one to two times per day.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.
  • Inactive ingredients

    Water, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cetyl Alcohol, Sorbitol, 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 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 imported components V-31490

    CVS® Quality

    Money Back Guarantee

    #971014

    M050733

    FP407

  • Principal Display Panel - Carton Label

    SKIN+
    PHARMACY

    ADVANCED
    ACNE
    THERAPY

    ACTIVE CLEARING LOTION
    with Microsponge    ® Technology

    2.5% Benzoyl Peroxide

    • clinically proven to kill acne-causing bacteria
    • clinically proven to effectively reduce inflammatory lesions
    • soothing, oil-free formula
    • unclogs pores
    • fragrance free

    DERMATOLOGIST TESTED

    exclusively at
    CVS/pharmacy

    1 FL OZ (30 mL)

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

    SKIN+PHARMACY

    ADVANCED
    ACNE
    THERAPY

    ACTIVE CLEARING LOTION
    with Microsponge    ® Technology

    2.5% Benzoyl Peroxide

    • clinically proven to kill acne-causing bacteria
    • clinically proven to effectively reduce inflammatory lesions
    • soothing, oil-free formula
    • unclogs pores
    • fragrance free

    DERMATOLOGIST TESTED

    exclusively at
    CVS/pharmacy

    1 FL OZ (30 mL)

    Principal Display Panel - Tube Label
  • INGREDIENTS AND APPEARANCE
    SKINPHARMACY ADVANCED ACNE THERAPY ACTIVE CLEARING 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-076
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzoyl peroxide (UNII: W9WZN9A0GM) (benzoyl peroxide - UNII:W9WZN9A0GM) benzoyl peroxide25 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:69842-076-011 in 1 CARTON06/01/2014
    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 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(69842-076) , PACK(69842-076) , LABEL(69842-076) , ANALYSIS(69842-076)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!