PREMIER VALUE TRIPLE ANTIBIOTIC PLUS - bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrochloride 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.

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Drug Facts

Active ingredients (in each gram)                                                                           Purpose

Bacitracin zinc 500 units ......................................................................................First aid antibiotic

Neomycin 3.5 mg ................................................................................................First aid antibiotic

Polymyxin B sulfate 10,000 units ..........................................................................First aid antibiotic

Pramoxine hydrochloride 10 mg ............................................................................Pain reliever

Uses

helps prevent infection and temporarily relieves pain due to minor cuts, scrapes, and burns.

Warnings

For external use only

Allergy alert: do not use if allergies to any of the ingredients

Do not use

Ask a doctor before use if you have

When using this product

do not use longer than 1 week

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    Adults and children 2 years and older:

Inactive ingredients

white petrolatum

Distributed By:

Chain Drug Consortium, LLC.

3301 N.W. Corporate Blvd. Suite 101

Boca Raton, FL 33431

image of carton labelEnter section text here

PREMIER VALUE TRIPLE ANTIBIOTIC PLUS 
bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-0129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68169-0129-51 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B11/04/2010
Labeler - TAI GUK PHARM. CO., LTD. (631101656)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIBusiness Operations
TAI GUK PHARM. CO., LTD.631101656manufacture

Revised: 11/2010
Document Id: c6606008-f13d-47f0-b836-4459b05021a9
Set id: fce6acbd-0387-4c84-9475-c67647bf3299
Version: 2
Effective Time: 20101104
 
TAI GUK PHARM. CO., LTD.