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Bacitracin Zinc by Galentic Pharma (India) Private Limited

Dosage form: ointment
Ingredients: Bacitracin Zinc 500[iU] in 1g
Labeler: Galentic Pharma (India) Private Limited
NDC Code: 50382-006

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 Zinc Ointment

• ACTIVE INGREDIENT
  • Active Ingredient (each gram contains)
    Bacitracin Zinc 500 units

• PURPOSE

First Aid Antibiotic

• USES

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

• WARNINGS For external use only

Do not use:

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

• Ask a doctor before use

in case of deep or puncture wounds, animal bites, or serious burns

• Stop use and ask a doctor if
  • condition persists or gets worse
  • rash or other allergic reaction develops

• KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center immediately.

• DIRECTIONS
  • Clean the affected area
  • Apply a small amount of this product (an amount 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

• OTHER INFORMATION
  • Store at 15° to 30°C (59° to 86°F)
  • Lot No. & Exp. Date. See box or crimp of tube.

• INACTIVE INGREDIENT

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,
Gandhidham-370 230, Gujrat. India

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Galentic

Bacitracin
Ointment
FIRST AID ANTIBIOTIC

BACITRACIN
ZINC

Helps to Heal Burns, Scrapes & Cuts
Prevents Infections

NET WT.
1 OZ. (28g)

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-006
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (Bacitracin) Bacitracin500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
PARAFFIN 
Packaging
#Item CodePackage Description
1NDC:50382-006-11144 PACKET in 1 CARTON
10.9 g in 1 PACKET
2NDC:50382-006-121 TUBE in 1 CARTON
214.2 g in 1 TUBE
3NDC:50382-006-131 TUBE in 1 CARTON
328 g in 1 TUBE
4NDC:50382-006-161 TUBE in 1 CARTON
4113 g in 1 TUBE
5NDC:50382-006-2012 JAR in 1 CASE
5425 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B08/07/2017
Labeler - Galentic Pharma (India) Private Limited (915110464)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited864201135ANALYSIS(50382-006), MANUFACTURE(50382-006), PACK(50382-006), REPACK(50382-006), STERILIZE(50382-006)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-006), MANUFACTURE(50382-006), PACK(50382-006), REPACK(50382-006), STERILIZE(50382-006)

Revised: 12/2017
 
Galentic Pharma (India) Private 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.

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