Your browser does not support JavaScript! TOPCARE ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [TOPCO ASSOCIATES LLC]
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TOPCARE ANTI-ITCH (diphenhydramine hydrochloride and zinc acetate) cream
[Topco Associates LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Drug Facts

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

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

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)

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
TOPCARE   ANTI-ITCH
diphenhydramine hydrochloride and zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-506
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride20 mg  in 1 g
Zinc Acetate (Zinc Cation) Zinc Cation1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
cetyl alcohol 
glyceryl monostearate 
methylparaben 
propylene glycol 
propylparaben 
water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-506-021 in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34809/20/2005
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(36800-506)

Revised: 1/2013
 
Topco Associates LLC

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