WINCO FOODS MAXIMUM STRENGTH ACNE TREATMENT (BENZOYL PEROXIDE) CREAM [WINCO FOODS, LLC]

WINCO FOODS MAXIMUM STRENGTH ACNE TREATMENT (BENZOYL PEROXIDE) CREAM [WINCO FOODS, LLC]
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NDC 67091-195-28
Set ID 3e5f87be-78d9-4501-8f8b-566a8684727a
Category HUMAN OTC DRUG LABEL
Packager WinCo Foods, LLC
Generic Name
Product Class
Product Number
Application Number PART333D
  • ACTIVE INGREDIENT

    Active ingredient                                                                Purpose

    Benzoyl peroxide 10%..................................................... Acne medication

  • PURPOSE

    Uses

    • For the treatmnet and prevention of acne pimples
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use if you have sensitive skin or are sensitive to benzoyl peroxide

  • WHEN USING

    When using this product

    • avoid contact with eyes, lips, and mouth
    • avoid contact with hair or dyed fabrics including carpet and clothing which may be bleached by this product
    • with other topical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one medication should be used unless directed by a doctor
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. More frequent use or higher concentration may aggravate skin irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration
  • ASK DOCTOR

    Stop use and ask a doctor if skin irritation becomes severe

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately

  • INDICATIONS & USAGE

    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 of the skin may occur, start with one application daily, then gradually increase to two to 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
    • use to prevent new pimples from forming
  • STORAGE AND HANDLING

    Other information

    • keep tightly closed
    • keep away from heat
    • store at 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    aluminum hydroxide, bentonite, dimethicone, glyceryl stearate SE, isopropyl myristate, methylparaben, petrolatum, polyethylene glycol 400, propylene glycol, propylparaben, tefose 63, water

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    WINCO FOODS, LLC

    BOISE, ID 83704

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WINCO FOODS MAXIMUM STRENGTH ACNE TREATMENT 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-195
    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
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BENTONITE (UNII: A3N5ZCN45C)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-195-281 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/01/2014
    Labeler - WinCo Foods, LLC (056098817)

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