SHOPKO ANTI-ITCH- diphenhydramine hydrochloride and zinc acetate cream 
Shopko Stores Operating Co., LLC

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.

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Shopko® Anti-Itch Cream

Drug Facts

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

Uses

temporarily relieves pain and itching associated with:

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

Other information

Inactive ingredients

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

Questions?

Call 1-866-923-4914

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

SHOPKO®

NDC 37012-089-02

Extra Strength
Anti-Itch Cream
Diphenhydramine hydrochloride 2% and Zinc acetate 0.1%

Antihistamine • Topical Analgesic • Skin Protectant

NET WT 1 OZ (28.4 g)

Principal Display Panel - 28.4 g Tube Carton
SHOPKO ANTI-ITCH 
diphenhydramine hydrochloride and zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-089
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M) diphenhydramine hydrochloride20 mg  in 1 g
zinc acetate (UNII: FM5526K07A) (zinc cation - UNII:13S1S8SF37) zinc acetate1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37012-089-021 in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/20/2005
Labeler - Shopko Stores Operating Co., LLC (023252638)
Registrant - Taro Pharmaceuticals U.S. A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(37012-089)

Revised: 4/2014
Document Id: c7be4695-4097-473e-a126-0d8e3516e9cc
Set id: 130119eb-b87e-4a07-8d2a-317369bfa541
Version: 1
Effective Time: 20140411
 
Shopko Stores Operating Co., LLC