TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-023-11	144 in 1 CARTON	08/07/2017
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50382-023-12	1 in 1 CARTON	08/07/2013
2		14.2 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 50382-023-13	1 in 1 CARTON	08/07/2013
3		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	08/07/2013

Labeler - Galentic Pharma (India) Private Limited (915110464)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	analysis(50382-023) , manufacture(50382-023) , pack(50382-023) , repack(50382-023) , sterilize(50382-023)