QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER - bacitracin zinc, neomycin sulfate, polymyxin-b sulfate, pramoxine hydrochloride ointment 
CHAIN DRUG MARKETING ASSOCIATION 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

Uses

help prevent infection and temporarily relieves pain due to

Warnings

For external use only

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

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  

Adults and children 2 years and older:

Children under 2 years: ask a doctor

Other information

Inactive ingredients

white petrolatum, Polysorbate 80, Stearic acid polyoxil 40, Methylparaben, Propylparaben, Purified Water

Distributed By Quality Choice

NOVI, MI 48376-0995

MADE IN KOREA

QC 94594

www.chaindrug.com

image of carton labelEnter section text here

Active Ingredients (in each gram)                                                                      Purpose

Bacitracin Zinc 500 units .................................................................................First aid antibiotic

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

Polymyxin-B Sulfate 10,000 units.....................................................................First aid antibiotic

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

QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER 
bacitracin zinc, neomycin sulfate, polymyxin-b sulfate, pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-945
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 SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 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)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-945-941 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B02/09/2012
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Revised: 2/2012
Document Id: 77e0cd5d-ee86-4a22-bb22-953136742c9c
Set id: dced282a-97f6-44a3-b3ab-bc19912844bd
Version: 7
Effective Time: 20120209
 
CHAIN DRUG MARKETING ASSOCIATION INC