Label: FOAMIMG ACNE FACE WASH- benzoyl peroxide 10% 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 24, 2018

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

  • ACTIVE INGREDIENT

    Active ingredient                                   Purpose
    Benzoyl Peroxide 10%...........................Acne Treatment

  • PURPOSE

  • Keep out of reach of children. If swallowed, get medicalhelp or contact a Poison Control Center right away.

  • 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

  • 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, Sodium
    Hydroxide, Glycolic Acid, Mineral Oil, Lactic Acid, Titanium
    Dioxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,
    Sodium PCA, Sodium Lauryl Sulfoacetate, Disodium Laureth
    Sulfosuccinate, Phenoxyethanol, Ethylhexylglycerin.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    FOAMIMG ACNE FACE WASH 
    benzoyl peroxide 10% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-666
    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
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    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:69842-666-05187 g in 1 TUBE; Type 0: Not a Combination Product03/29/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/29/2018
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(69842-666) , label(69842-666)