DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE cream

Diphenhydramine Hydrochloride and Zinc Acetate by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride and Zinc Acetate by is a Otc medication manufactured, distributed, or labeled by Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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?

Call 1-866-923-4914

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Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Extra Strength

Anti-Itch Cream
Diphenhydramine Hydrochloride 2%
and Zinc Acetate 0.1%

Topical Analgesic Skin Protectant

NET WT 1 oz (28.4 g)

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE 
diphenhydramine hydrochloride and zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51672-2089
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	20 mg  in 1 g
Zinc Acetate (UNII: FM5526K07A) (zinc cation - UNII:13S1S8SF37)	Zinc Acetate	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
cetyl alcohol (UNII: 936JST6JCN)
glyceryl monostearate (UNII: 230OU9XXE4)
PEG-100 stearate (UNII: YD01N1999R)
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-2089-2	1 in 1 CARTON	09/20/2005
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	09/20/2005

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceutical Inc.		206263295	MANUFACTURE(51672-2089)