MAJOR BACITRACIN ZINC- bacitracin zinc ointment

Major Bacitracin Zinc by

Drug Labeling and Warnings

Major Bacitracin Zinc 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 500

Purpose

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 20º-25ºC (68° to 77°F)

Inactive ingredient

Petrolatum

Questions? 1-800-616-2471

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Carton Label

Major NDC: 0904-6679-67

Bacitracin Zinc Ointment USP

Bacitracin Zinc 500 units

144 Unit dose Packets

First Aid Antibiotic Ointment

NET WT. 0.9g (0.03oz)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Packet Label

Major NDC: 0904-6679-67

Bacitracin Zinc Ointment

Bacitracin Zinc 500 Units 

144 Unit Dose Packets

First Aid Antibiotic Ointment

Protection against Infection 

NET WT. 0.9g (0.03oz)

INGREDIENTS AND APPEARANCE

MAJOR BACITRACIN ZINC 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6679
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)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6679-67	144 in 1 CARTON	09/28/2018
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	09/28/2018

Labeler - Major Pharmaceuticals (191427277)

Registrant - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(0904-6679)