SHOPKO TRIPLE ANTIBIOTIC - bacitracin zinc, neomycin sulfate, polymyxin-b sulfate 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 Ingredients (each gram contains)                                                                   Purpose

Bacitracin zinc 400 units ........................................................................................Antibiotic

Neomycin Sulfate equivalent to 3.5mg of Neomycin Base ........................................Antibiotic

Polymyxin-B Sulfate 5000 units ..............................................................................Antibiotic

Uses

first aid to help prevent infection in

Warnings

For external use only

Do not use

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

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

Directions

Other information

Inactive ingredients

liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

Distributed by

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

www.ueccorp.com

Made in Korea

image of carton labelEnter section text here

SHOPKO TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin-b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-0022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN ZINC - UNII:89Y4M234ES) BACITRACIN ZINC400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68169-0022-81 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B12/20/2010
Labeler - TAI GUK PHARM. CO., LTD. (631101656)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIBusiness Operations
TAI GUK PHARM. CO., LTD.631101656manufacture

Revised: 12/2010
Document Id: cb15cade-4fca-43a3-b4fb-835c9f0f5f7f
Set id: 149b5f9f-d241-4df2-b43c-293f2bd8ad0c
Version: 2
Effective Time: 20101220
 
TAI GUK PHARM. CO., LTD.