Bacitracin Zinc Ointment

Bacitracin Zinc Ointment

Drug Labeling and Warnings

Drug Details

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BACITRACIN ZINC- bacitracin zinc 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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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)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50382-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50382-006-11144 in 1 CARTON08/07/2017
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC: 50382-006-121 in 1 CARTON08/07/2013
214.2 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 50382-006-131 in 1 CARTON08/07/2013
328 g in 1 TUBE; Type 0: Not a Combination Product
4NDC: 50382-006-161 in 1 CARTON08/07/2013
4113 g in 1 TUBE; Type 0: Not a Combination Product
5NDC: 50382-006-2012 in 1 CASE08/07/2017
5425 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B08/07/2013
Labeler - Galentic Pharma (India) Private Limited (915110464)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited864201135ANALYSIS(50382-006) , MANUFACTURE(50382-006) , PACK(50382-006) , REPACK(50382-006) , STERILIZE(50382-006)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-006) , MANUFACTURE(50382-006) , PACK(50382-006) , REPACK(50382-006) , STERILIZE(50382-006)

Revised: 7/2018
 
Galentic Pharma (India) Private Limited


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