BACITRACIN - bacitracin ointment 
Galentic Pharma (India) Priva Te 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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Bacitracin Ointment

Active ingredient               Purpose
Bacitracin 500 Units                Antibiotic

Purpose:

First aid to help prevent infection.

Warnings:

For external use only

Dosage and Administration

Directions:

  • clean the affected areas
  • apply a small amount of product (an amountb equal to the surface area of the tip of the finger) on the area 1 to 3 times daily.
  • may be covered with a sterile bandage

Indications and Usage

First aid to help prevent infection in:

  • minor cuts
  • scrapes
  • burns

Stop Use and ask a doctor if:

  • the condition persists or gets worse, or if a rash or other allergic reaction develops.

Do Not Use if:

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away

Ask a doctor before use:


Other information

Inactive ingredients

Light Mineral Oil, White Petrolatum

Principal Display Panel

Bacitracin Ointment:

Gal Bacitracin.jpg

Gal Bacitracin

BACITRACIN 
bacitracin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50382-005-0128.35 g in 1 TUBE
2NDC:50382-005-0214.17 g in 1 TUBE
3NDC:50382-005-0356.7 g in 1 TUBE
4NDC:50382-005-04113.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/02/2013
Labeler - Galentic Pharma (India) Priva Te Limited (918531450)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Priva Te Limited918531450manufacture(50382-005)

Revised: 8/2013
Document Id: 2a35f493-11e4-49ab-bacd-3b1eede3d97a
Set id: 68449090-6c59-4046-b721-ebe572de0595
Version: 1
Effective Time: 20130806
 
Galentic Pharma (India) Priva Te Limited