WINCO ORIGINAL STRENGTH ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE) CREAM [WINCO FOODS, LLC]

WINCO ORIGINAL STRENGTH ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATE) CREAM [WINCO FOODS, LLC]
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NDC 67091-277-28
Set ID ae74e163-ba1a-4d1e-aaeb-9976bd202674
Category HUMAN OTC DRUG LABEL
Packager WinCo Foods, LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredients.............................................................................Purposes

    Diphenhydramine HCl 1%...................................................... Topical analgesic

    Zinc acetate 0.1%...................................................................... Skin protectant

  • PURPOSE

    Uses

    temporarily relieves pain and itching associated with:

    • insect bites
    • minor burns
    • minor skin irritations
    • sunburn
    • minor cuts
    • scrapes
    • rashes due to poison ivy, oak, and sumac

    dries the oozing and weeping of poison ivy, poison oak, and poison sumac

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • with any other product containing diphenhydramine, even one taken by mouth
    • on large areas of the body
  • ASK DOCTOR

    Ask a doctor before use

    • on chicken pox
    • on measles
  • WHEN USING

    When using this product, avoid contact with eyes.

  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • do not use more than directed
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
    • protect from heat, humidity, and light
  • INACTIVE INGREDIENT

    Inactive ingredients cetanol, methylparaben, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    WINCO FOODS, LLC

    BOISE, ID 83704

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    WinCo Anti-itch Cream Original 1 oz

  • INGREDIENTS AND APPEARANCE
    WINCO ORIGINAL STRENGTH ANTI-ITCH 
    diphenhydramine hydrochloride, and zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-277
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE10 mg  in 1 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-277-281 in 1 CARTON02/09/2015
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/09/2014
    Labeler - WinCo Foods, LLC (056098817)

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