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

Major Triple Antibiotic by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (In each gram)

Bacitracin 400

Neomycin 3.5 mg

Polymyxin B 5,000 units

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Uses

First aid to help prevent infection in minor:

• cuts
• scrapes
• burns

Warnings

For external use only

Allergy Alert do not use if you are allergic to any of the ingredients 

Do not use

• in or near the eyes
• on large areas of the body

Consult a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not use longer than 1 week

Stop use and consult a doctor if

• condition persists or gets worse
• symptoms last for more than 7 days or clear up and come back within a few days
• a rash or other allergic reaction develops

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

Directions

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

Other information

• Store at a controlled room temperature 20°C to 25°C(68º-77ºF)

Inactive ingredient

Petrolatum

Questions? 1-800-616-2417

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Carton Label

Major NDC: 0904-6680-67

Triple Antibiotic Ointment

144 Unit Dose Packets 

Bacitracin Zinc Neomycin Sulfate Polymyxin-B Sulfate
First Aid Antibiotic Ointment

Prevents infaction in Minor 

• Cuts 
• Burns
• Scraps 

NET WT. 0.9 g (0.03 oz ) PACKETS

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Tube Label

Major NDC: 0904-6680-67

Triple Antibiotic OintmentBacitracin Zinc Neomycin Sulfate Polymyxin-B Sulfate
First Aid Antibiotic Ointment

First Aid Treatment for Minor Cuts, Scrapes and Burns

NET WT 0.9g (0.03oz)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6680
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
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6680-67	144 in 1 CARTON	10/04/2018
1		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 final	part333B	10/04/2018

Labeler - Major Pharmaceuticals (191427277)

Registrant - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(0904-6680)