WESTERN FAMILY DIAPER RASH - zinc oxide ointment 
TAI GUK PHARM. CO., LTD.

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.

----------

Drug Facts

Active Ingredient                                                                        Purpose

Zinc oxide, 40% ........................................................................Skin protectant

Uses

For external use only

Do not use over deep or puncture wounds, infections or lacerations

When using this product avoid contact with the eyes

Stop use and ask a doctor if condition worsens or does not improve within 7 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

BHA, cod liver oil (high in vitamins A and D), fragrance, lanolin, light mineral oil, methylparaben, petrolatum, purified water, talc, tartrazine yellow #4 (FD and C yellow #4)

Proudly Distributed By:

Western Family Foods, Inc.

P.O. Box 4057, Portland, OR 97208 U.S.A.

Copyright 2010 Marca Registrada

www.westernfamily.com

image of carton labelEnter section text here

WESTERN FAMILY DIAPER RASH 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-0375
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.40 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
COD LIVER OIL (UNII: BBL281NWFG)  
LANOLIN (UNII: 7EV65EAW6H)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68169-0375-41 in 1 CARTON
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/05/2010
Labeler - TAI GUK PHARM. CO., LTD. (631101656)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIBusiness Operations
TAI GUK PHARM. CO., LTD.631101656manufacture

Revised: 10/2010
Document Id: 65933290-eab5-456c-9ea5-c9d5ff3c614c
Set id: 2c0f0018-6389-4282-aa18-416b9329b8ca
Version: 1
Effective Time: 20101005
 
TAI GUK PHARM. CO., LTD.