Label: WALGREENS ORIGINAL STRENGTH ANTI ITCH- diphenhydramine hydrochloride, zinc acetate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 27, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Diphenhydramine hydrochloride 1%Topical analgesic
    Zinc acetate 0.1%Skin protectant
  • Uses

    Temporarily relieves pain and itching associated with:

    • insect bites
    • minor burns
    • sunburn
    • scrapes
    • minor skin irritations
    • minor cuts

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

  • Warnings

    For external use only.

    Avoid contact with eyes.

    Do not use

    • more than directed
    • on large areas of the body
    • with any product containing diphenhydramine even one taken by mouth

    Ask a doctor before use

    • on chicken pox
    • on measles

    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

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

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

  • Directions

    • do not use more than directed
    • Adults and children 2 years of age and older: apply to affected area up to 4 times daily
    • Children under 2 years of age: ask a doctor
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    cetearyl alcohol (and) polysorbate 60, DMDM hydantoin, glyceryl stearate, isopropyl myristate, methylparaben, mineral oil, propylparaben, purified water

  • Questions or comments?

    1-866-323-0107

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Itch Relief
    Cream
    DIPHENHYDRAMINE HYDROCHLORIDE USP 1% / ANTI-ITCH CREAM

    NET WT 1 OZ (28 g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    WALGREENS ORIGINAL STRENGTH ANTI ITCH 
    diphenhydramine hydrochloride, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE1 g  in 100 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-4115-281 in 1 CARTON09/27/2013
    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 drugM01709/27/2013
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(0363-4115)
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