LEADER POLY BACITRACIN- bacitracin zinc polymixin b sulfate ointment

Leader Poly Bacitracin by

Drug Labeling and Warnings

Leader Poly Bacitracin by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110 dba LEADER, 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

Acrive Ingredient

Polymixin B Sulfate 10,000 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

Ask Doctor before Use if you have

deep puncture wounds.

animal bites

serious burns.

Stop Use and Ask Doctor if

• The 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 Ingredients

mineral oil, white petrolatum

Questions

Call 1-888-296-9067

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Other Information

Store Between 20°C to 25°C (68° to 77°F)

Distributed By:

Cardinal Health

Dublin, Ohio 43017

www.myleader.com

1-800-200-6313

Essential to Care™ Since 1979

©2024 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are he property of their respective owners.

Packaging

INGREDIENTS AND APPEARANCE

LEADER POLY BACITRACIN 
bacitracin zinc polymixin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0694
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
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0694-1	1 in 1 BOX	08/15/2024
1		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	08/15/2024

Labeler - Cardinal Health 110 dba LEADER (063997360)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)