Label: ADVANCED 3 IN 1 EXFOLIATING CLEANSER- benzoyl peroxide 5.0% cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated December 8, 2017

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  • ACTIVE INGREDIENT

    Active ingredient                                                  Purpose
    Benzoyl Peroxide 5%.............................................Acne Treatment

  • PURPOSE

  • INDICATIONS & USAGE

    Use For the 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 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 ask a doctor if irritation becomes severe.

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

  • 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,
    Polyacrylamide, C13-14 Isoparaffin,
    Cocamidopropyl Betaine, Jojoba Esters,
    Laureth-7, Phenoxyethanol,
    Ethylhexylglycerin.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ADVANCED 3 IN 1 EXFOLIATING CLEANSER 
    benzoyl peroxide 5.0% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-839
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    C13-14 Isoparaffin (UNII: E4F12ROE70)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Laureth-7 (UNII: Z95S6G8201)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-839-04148 mL in 1 TUBE; Type 0: Not a Combination Product06/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/15/2017
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(69842-839) , label(69842-839)