Label: CRMY ACNE WASH CVS- benzoyl peroxide 4.00% 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 5, 2017

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  • Active ingredient                       Purpose

    Benzoyl Peroxide – 4.00%          Acne Treatment

  • PURPOSE

  • INDICATIONS & USAGE

    ​Uses​ for treatment of acne

  • WarningsFor 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 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 eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occurs, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

    Keep out of reach of the children
    If product is swallowed, get medical help or contact a Poison Control Center right away

  • 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 ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetearyl Alcohol, Cocamidopropyl Betaine, Glycerin, Glycolic Acid, Dimethyl Isosorbide, Imidazolidinyl Urea, Lactic Acid, Methylparaben, Mineral Oil, Potassium Lauryl Sulfate, Purified Water, Sodium Cocoyl Isethionate, Sodium , Hydroxide, Sodium Lauryl Sulfate, Sodium PCA, Titanium Dioxide

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    CRMY ACNE WASH  CVS
    benzoyl peroxide 4.00% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-031
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    IMIDUREA (UNII: M629807ATL)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POTASSIUM LAURYL SULFATE (UNII: PS6855FO7F)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-031-051 in 1 CARTON11/26/2014
    1204 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/26/2014
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(69842-031) , label(69842-031)
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