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Bacitracin by Galentic Pharma (India) Priva Te Limited

Dosage form: ointment
Ingredients: BACITRACIN 500[iU] in 1g
Labeler: Galentic Pharma (India) Priva Te Limited
NDC Code: 50382-005

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.

Bacitracin Ointment

Active ingredient               Purpose
Bacitracin 500 Units                Antibiotic


First aid to help prevent infection.


For external use only

Dosage and Administration


  • 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:
  • in case of deep or puncture wounds
  • animal bites
  • serious burns

Other information
  • store at controlled room temperature 15°-30° C (59°-86° F)

Inactive ingredients

Light Mineral Oil, White Petrolatum

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Bacitracin Ointment:

Gal Bacitracin.jpg

bacitracin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage Description
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)
Galentic Pharma (India) Priva Te Limited918531450manufacture(50382-005)

Revised: 08/2013
Galentic Pharma (India) Priva Te Limited

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.