Label: TOPCARE ANTI-ITCH- diphenhydramine hydrochloride and zinc acetate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Diphenhydramine hydrochloride 2% Topical analgesic
    Zinc acetate 0.1% Skin protectant
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  • Uses

    • temporarily relieves pain and itching associated with:
      • insect bites
      • minor burns
      • sunburn
      • minor skin irritations
      • minor cuts
      • scrapes
      • rashes due to poison ivy, poison oak, and poison sumac
    • dries the oozing and weeping of poison ivy, poison oak, and poison sumac
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  • Warnings

    For external use only

    Do not use

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

    Ask a doctor before use

    • on chicken pox
    • on measles

    When using this product avoid contact with eyes

    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

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

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  • Directions

    • do not use more often 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
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  • Other information

    • To open: unscrew cap, use pointed end of cap to puncture seal.
    • store at 20° to 25°C (68° to 77°F)
    • see carton or tube crimp for lot number and expiration date
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  • Inactive ingredients

    cetyl alcohol, glyceryl stearate, glyceryl stearate/PEG-100 stearate, methylparaben, propylene glycol, propylparaben and purified water

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  • QUESTIONS?

    1-888-423-0139

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    TOPCO ASSOCIATES LLC
    7711 GROSS POINT ROAD
    SKOKIE, IL 60077

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  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    TopCare®

    EXTRA STRENGTH

    Anti-Itch Cream 2%

    DIPHENHYDRAMINE HYDROCHLORIDE 2%
    AND ZINC ACETATE 0.1%

    QUALITY
    GUARANTEED

    COMPARE TO
    BENADRYL®
    active ingredient*

    NET WT 1 OZ (28.4 g)

    PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    TOPCARE   ANTI-ITCH
    diphenhydramine hydrochloride and zinc acetate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-506
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 20 mg  in 1 g
    Zinc Acetate (Zinc Cation) Zinc Cation 1 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    cetyl alcohol  
    glyceryl monostearate  
    methylparaben  
    propylene glycol  
    propylparaben  
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-506-02 1 in 1 CARTON
    1 28.4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part348 09/20/2005
    Labeler - Topco Associates LLC (006935977)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(36800-506)
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