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

Triple Antibiotic by

Drug Labeling and Warnings

Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Bacitracin Zinc 400 Units

Purpose

First Aid Antibiotic

Active ingredient

Neomycin Sulfate 3.5 mg

Purpose

First Aid Antibiotic

Active Ingredient

Polymyxin B Sulfate 5000 Units

Purpose

First Aid Antibiotic

Uses

First Aid to help prevent infection in minor:

• cuts
• scrapes
• burns

Warnings

For External Use Only.

Ask Doctor before use if you have

deep or puncture wounds

animal bites

serious burns

Do Not Use

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

Stop Use and Ask Doctor if

• If conidition persists or gets worse
• You need to use longer than 1 week
• A rash or allergic reaction develops

Directions

• Clean the affected area and dry thoroughly
• Apply a small amount of the 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

Inactive Ingredients

light mineral oil and white petrolatum

Questions

Call 1-888-296-9067

Storage Information

Store at 20° to 25°C (68° to 77°F).

Keep out of reach of children

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

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Reorder: R519-545

Package Label

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-135-10	10 in 1 CARTON	10/23/2023
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 69396-135-25	25 in 1 CARTON	10/23/2023
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	10/23/2023

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)