GOOD NEIGHBOR PHARMACY DIAPER RASH - zinc oxide cream 
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.

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Drug Facts

Active ingredient                                                               Purpose

Zinc oxide 10% ................................................................Skin protectant

Uses

Warnings

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

White petrolatum, talc, purified lanolin, liquid paraffin, triethanolamine, aloe vera gel, tocoperol acetate, butylated hydroxyloluene, methyl parahydroxybenzoate, purified water

Distributed by:

Amerisource Bergen Corporation

1300 Morris Drive

Chesterbrook, PA 19087

image of carton labelEnter section text here

GOOD NEIGHBOR PHARMACY DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-4058
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.10 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
TALC (UNII: 7SEV7J4R1U)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68169-4058-21 in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/20/2010
Labeler - TAI GUK PHARM. CO., LTD. (631101656)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIBusiness Operations
TAI GUK PHARM. CO., LTD.631101656manufacture

Revised: 9/2010
Document Id: e1503304-00b8-4364-b435-0d1ed448eff3
Set id: d9c5171c-9f76-4254-8e55-c62aafedccf3
Version: 2
Effective Time: 20100920
 
TAI GUK PHARM. CO., LTD.