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Triple Antibiotic by Galentic Pharma (India) Private Limited

Medically reviewed on January 9, 2018

Dosage form: ointment
Ingredients: Bacitracin Zinc 400[iU] in 1g, Neomycin Sulfate 5mg in 1g, Polymyxin B Sulfate 5000[iU] in 1g
Labeler: Galentic Pharma (India) Private Limited
NDC Code: 50382-023

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.

Triple Antibiotic Ointment

• ACTIVE INGREDIENT

Active ingredient (in each gram)  Purpose
Bacitracin Zinc 400 UnitsFirst Aid Antibiotic
Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)First Aid Antibiotic
Polymyxin B Sulfate 5000 UnitsFirst 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

• ASK A DOCTOR BEFORE USE IF YOU HAVE
  • Animal bites
  • Serious burns
  • Deep or puncture wounds

• STOP USE AND ASK A DOCTOR IF
  • You need to use longer than 1 week
  • 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 areas
  • apply a small amount of 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 controlled room temperature 15°-30° C (59°-86° F)

• INACTIVE INGREDIENTS

White Petrolatum

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

Triple Antibiotic
Ointment

FIRST AID ANTIBIOTIC

Helps Prevent Infection
in Minor Cuts, Scrapes and Burns

Bacitracin zinc, Neomycin Sulfate, Polymyxin-B Sulfate

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-023
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (Bacitracin) Bacitracin400 [iU]  in 1 g
Neomycin Sulfate (Neomycin) Neomycin Sulfate5 mg  in 1 g
Polymyxin B Sulfate (Polymyxin B) Polymyxin B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:50382-023-11144 PACKET in 1 CARTON
10.9 g in 1 PACKET
2NDC:50382-023-121 TUBE in 1 CARTON
214.2 g in 1 TUBE
3NDC:50382-023-131 TUBE in 1 CARTON
328 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 (915110464)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited864201135ANALYSIS(50382-023), MANUFACTURE(50382-023), PACK(50382-023), REPACK(50382-023), STERILIZE(50382-023)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-023), MANUFACTURE(50382-023), PACK(50382-023), REPACK(50382-023), STERILIZE(50382-023)

 
Galentic Pharma (India) Private Limited

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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