MAJOR BACITRACIN- bacitracin zinc ointment

Major Bacitracin by

Drug Labeling and Warnings

Major Bacitracin 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 500 Units per gram

Purpose

First Aid Antibiotic

Uses

First Aid to help prevent infection in

• minor cuts
• scrapes
• burns

Warnings

For External Use Only.

Do Not Use

• in eyes
• over large areas of the body
• if you are allergic to any of the ingredients, due to the possiblity of anaphylactic shock
• longer than 1 week unless directed by a doctor

Ask Doctor before Use

In care of deep puncture wounds, animal bites, or serious burns.

Stop Use and Ask Doctor if

• Before use in case of deep puncture wounds, animal bites or serious burns
• 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, 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

Packaging

INGREDIENTS AND APPEARANCE

MAJOR BACITRACIN 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7023-67	144 in 1 CARTON	05/29/2020
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 Drug	M004	04/01/2020

Labeler - Major Pharmaceuticals (191427277)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)