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 Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each gram)	Purpose
Bacitracin zinc USP 400 units	First aid antibiotic
Neomycin sulfate USP 3.5 mg	First aid antibiotic
Polymyxin B sulfate USP 5,000 units	First aid antibiotic

Uses

first aid to help prevent infection in minor:

• cuts
• scrapes
• burns

Warnings

For external use only.

Do not use

• if you are allergic to any of the ingredients
• in the eyes
• over large areas of the body

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

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 right away.

Directions

• clean the affected area
• apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
• may be covered with a sterile bandage

Other information

• To open: unscrew cap, pull tab to remove foil seal
• store at 20° to 25°C (68° to 77°F)
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Original Strength

Triple Antibiotic
Ointment

Bacitracin Zinc USP Neomycin Sulfate USP Polymyxin B Sulfate USP

First Aid Antibiotic Ointment

NET WT 1 oz (28.4 g)

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: 51672-2120
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	3.5 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
cocoa butter (UNII: 512OYT1CRR)
cottonseed oil (UNII: H3E878020N)
olive oil (UNII: 6UYK2W1W1E)
sodium pyruvate (UNII: POD38AIF08)
.alpha.-tocopherol (UNII: H4N855PNZ1)
petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-2120-1	1 in 1 CARTON	12/15/2015
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51672-2120-2	1 in 1 CARTON	12/15/2015
2		28.4 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 51672-2120-3	1 in 1 CARTON	12/15/2015
3		60 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	12/15/2015

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)