BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE- bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment 
Galentic Pharma (India) Private Limited

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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Galentic Triple Antibiotic Ointment

Active ingredient (in ea. gram)                                                Purpose
Bacitracin Zinc 400 Units                                                          First Aid Antibiotic

Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)              First Aid Antibiotic

Polymyxin B Sulfate 5000 Units                                                 First Aid Antibiotic

Purpose:

First aid to help prevent infection in:

Indications and Usage:


Other information

Inactive ingredients:

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Warnings

For external use only

Dosage and Administration

Do Not Use:

Stop use and ask a doctor if

Principal Display Panel

Galentic Triple Antibiotic Ointment

Gal Triple.jpg

Triple Antibiotic Ointment

BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE 
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50382-008-0128.35 g in 1 TUBE
2NDC:50382-008-0214.17 g in 1 TUBE
3NDC:50382-008-0356.7 g in 1 TUBE
4NDC:50382-008-04113.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/07/2013
Labeler - Galentic Pharma (India) Private Limited (918531450)

Revised: 8/2013
Document Id: cae22cb8-66e4-4702-80c2-89428b37f1cc
Set id: f562f46c-a764-44f5-b8f4-2d4e97489691
Version: 1
Effective Time: 20130807
 
Galentic Pharma (India) Private Limited