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 Front Pharmaceutical PLC, Trifecta Pharmaceuticals USA, FRONT PHARMACEUTICAL PLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (each gram contains)

Bacitracin zinc 400 units
Neomycin sulfate 3.5 mg 
Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

INDICATIONS & USAGE

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

WARNINGS

Warnings    For external use only.

Do not use● in the eyes                             ● over large areas of the body

                   ● if you are allergic to any of the ingredients.

Ask a doctor before use if you have

● deep or puncture wounds                     ● animal bites                        ● serious burns.

Stop use and ask a doctor if● condition persists or gets worse

● you need to use longer than 1 week

● a rash or other allergic reaction develops 

Directions

 ● clean the affected area and dry thoroughly.

 ● 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.

INACTIVE INGREDIENT

Inactive ingredient Mineral Oil, White Petrolatum

Other information

● store at 20° to 25°C ( 68° to 77°F)

QUESTIONS

Questions?  Call 1-888-296-9067

SPL UNCLASSIFIED SECTION

Distributed by:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL 33301, USA

1-888-296-9067

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: 69571-888
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'U]  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 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69571-888-05	8000 in 1 BAG	04/08/2025
1		0.5 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	04/08/2025

Labeler - Front Pharmaceutical PLC (530897792)

Registrant - Trifecta Pharmaceuticals USA (079424163)

Establishment
Name	Address	ID/FEI	Business Operations
FRONT PHARMACEUTICAL PLC		530897792	manufacture(69571-888)