LEADER POLY BACITRACIN- first aid antibiotic 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, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (In each gram)

Bacitracin 500 units 

Polymyxin B Sulfate 10,000 units 

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? Call; 1-800-222-1087

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Carton Label

Leader Major NDC: 70000-0093-1

Poly Bacitracin Zinc Ointment USP

Bacitracin Zinc 500 units

Polymixin B sulfate 10,000 units

First Aid Antibiotic Ointment

NET WT. 0.5 oz (14g)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Tube Label

Leader NDC: 70000-0093-1

Poly Bacitracin Zinc Ointment

Bacitracin Zinc 500 Units

Polymixin B Sulfate 10,000 units 

First Aid Antibiotic Ointment

Protection against Infection 

NET WT. 0.5 oz ( 14g) 

INGREDIENTS AND APPEARANCE

LEADER POLY BACITRACIN 
first aid antibiotic ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0093
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
Petrolatum (UNII: 4T6H12BN9U)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0093-1	1 in 1 CARTON	06/01/2021
1		14 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	06/01/2021

Labeler - Cardinal Health 110, Inc. (063997360)

Registrant - Cardinal Health 110, Inc. (063997360)