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TopCare

Topco Associates LLC
Taro Pharmaceuticals U.S.A., Inc.

TopCare Anti-Itch Cream


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

TopCare 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

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.

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

TopCare 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

Inactive ingredients

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

QUESTIONS?

1-888-423-0139

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

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)

TopCare

TopCare

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 20 mg
ZINC ACETATE zinc 1 mg

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 28.4 in 1 TUBE
2 NDC:36800-506-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2005-09-20


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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