Label: CREAMY ACNE FACE WASH- benzoyl peroxide 4% 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 April 23, 2018

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

  • ACTIVE INGREDIENT

    Active ingredient                               Purpose
    Benzoyl Peroxide 4%.........................Acne Treatment

  • PURPOSE

  • INDICATIONS & USAGE

    Use For the treatment of acne.

  • WARNINGS

    Warnings
    For external use only.
    Do not use if you have very sensitive skin or if you
    are sensitive to benzoyl peroxide.
    When using this product • skin irritation and
    dryness are 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 and consult a doctor if • irritation becomes severe.

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Directions • Wet face • Apply to hands and work
    into a lather • Massage face gently • Rinse thoroughly
    and pat dry • Cleanse twice a day • If going outside,
    apply sunscreen after using this product. If irritation or
    sensitivity develops, stop use of both products and
    consult a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients
    Water, Sodium Cocoyl Isethionate, Cetearyl Alcohol,
    Cocamidopropyl Betaine, Potassium Lauryl Phosphate,
    Glycerin, Disodium Laureth Sulfosuccinate, Sodium
    Hydroxide, Glycolic Acid, Mineral Oil, Lactic Acid, Titanium
    Dioxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,
    Sodium PCA, Dimethyl Isosorbide, Sodium Lauryl
    Sulfoacetate, Phenoxyethanol, Ethylhexylglycerin.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    CREAMY ACNE FACE WASH 
    benzoyl peroxide 4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-444
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Dimethyl Isosorbide (UNII: SA6A6V432S)  
    Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    Lactic Acid (UNII: 33X04XA5AT)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Potassium Lauryl Phosphate (UNII: C4QT53N4MK)  
    Sodium Cocoyl Isethionate (UNII: 518XTE8493)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Lauryl Sulfoacetate (UNII: D0Y70F2B9J)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-444-05204 g in 1 TUBE; Type 0: Not a Combination Product06/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/20/2018
    Labeler - CVS (062312574)
    Registrant - Product Quest Mdf (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mdf927768135manufacture(69842-444) , label(69842-444)