Diphenhydramine Hydrochloride and Zinc Acetate

Dosage form: cream
Ingredients: Diphenhydramine Hydrochloride 2g in 100g, Zinc Acetate 0.1g in 100g
Labeler: Taro Pharmaceuticals U.S.A., Inc.
NDC Code: 51672-2089

Disclaimer: 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.

Anti-Itch Cream 2% Diphenhydramine Hydrochloride

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 room temperature
  • 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

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.

Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Anti-Itch
Cream 2%
Diphenhydramine Hydrochloride

Extra Strength

  • Topical Analgesic / Antihistamine
  • Skin Protectant

NET WT 1 oz (28.4 g)

DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE 
diphenhydramine hydrochloride and zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2089
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride2 g  in 100 g
Zinc Acetate (Zinc) Zinc Acetate0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
cetyl alcohol 
glyceryl monostearate 
methylparaben 
propylene glycol 
propylparaben 
water 
Packaging
#Item CodePackage Description
1NDC:51672-2089-21 TUBE (TUBE) in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/01/2008
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIOperations
Taro Pharmaceutical Inc.206263295MANUFACTURE(51672-2089)

Revised: 04/2012
 
Taro Pharmaceuticals U.S.A., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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