MAJOR TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin, polymyxin b sulfat ointment

Major Triple Antibiotic by

Drug Labeling and Warnings

Major Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, 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 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 you need to use longer than 1 week
• The condition persists or gets worse
• A rash or allergic reaction develops

Directions

• Clean the affected area
• 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

mineral oil and white petrolatum

Questions

Call 1-800-616-2471

Storage Information

Avoid excessive heat and humidity

Store at room temperature 15° to 30°C (59° to 86°F).

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Other Information

Tamper evident. Do not use if packet is torn, cut or opened.

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive

Suite 233

Livonia, MI 48152

Product of USA

OVERDOSAGE

Packaging

INGREDIENTS AND APPEARANCE

MAJOR TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin, polymyxin b sulfat ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-8805
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-8805-67	144 in 1 CARTON	05/29/2020
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0904-8805-31	1 in 1 BOX	08/20/2024
2		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 Drug	M004	04/20/2020

Labeler - Major Pharmaceuticals (191427277)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)