Label: VANISHING ACNE CVS- 10% benzoyl peroxide acne medication cream

  • 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 December 6, 2017

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

  • Active ingredient

    Benzoyl Peroxide 10%

  • Purpose

    Acne Treatment

  • Uses

    • for the treatment of acne
  • Warnings

    For external use only

  • Do not use

    • if you have very sensitive skin or are sensitive to benzoyl peroxide
  • 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.
    • rinse right away with water if it gets in eyes
    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with the eyes, lips, and mouth.
    • avoid contact with hair and dyed fabrics, which may be bleached by this product
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
  • Stop use adn ask a doctor if

    skin irritation becomes severe

  • Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • cleanse the skin thoroughly before applying medication
    • cover the entire affected area with a thin layer one to three times a day
    • because excessive drying og 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.
    • if going outside, use a sunscreen. Allow product to dry, then follow direction in the sunscreen labeling. If sensitivity develops, discontinue use of both products and consult a doctor.
  • Other information

    • keep tightly closed
    • keep away from heat
  • Inactive ingredients

    Water, Gluconolactone, Glyceryl Stearate, PEG-100 Stearate, Glycerin, PEG-40 Stearate, Cetyl Alcohol, Dimethicone, Magnesium Aluminum Silicate, Xanthan Gum, Phenoxyethanol, Ammonium Hydroxide, Isopropylparabem, Butylparaben, Isobutylparaben, Arginine, Titanium Dioxide.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    VANISHING ACNE  CVS
    10% benzoyl peroxide acne medication cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    AMMONIA (UNII: 5138Q19F1X)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    ARGININE (UNII: 94ZLA3W45F)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-048-011 in 1 CARTON12/13/2013
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/13/2013
    Labeler - CVS (062312574)
    Registrant - Product Quest Mff, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mff, LLC927768135manufacture(69842-048)