WESTERN FAMILY ITCH RELIEF  - diphenhydramine hydrochloride, zinc acetate cream 
Western Family Food, Inc.

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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Drug Facts

Active ingredients                                                                                                     Purpose

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

Ask a doctor before use

When using this product

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Directions

Other information

Inactive ingredients cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, and purified water

Proudly Distributed by:

Western Family Foods, Inc.

P.O. Box 4057

Portland, OR 97208 U.S.A.

Made in Korea

image of carton label

WESTERN FAMILY ITCH RELIEF  
diphenhydramine hydrochloride, zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-053
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE ANHYDROUS0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-053-281 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/30/2013
Labeler - Western Family Food, Inc. (192166072)

Revised: 4/2013
Document Id: b2f1c850-5157-4b73-b008-9a4dae2c4bb5
Set id: 8f2f4671-67a9-4c18-ba5f-8fc2b9d01990
Version: 19
Effective Time: 20130430
 
Western Family Food, Inc.