LEADER BACITRACIN ZINC- bacitracin zinc ointment

Leader Bacitracin Zinc by

Drug Labeling and Warnings

Leader Bacitracin Zinc 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

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
• 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

• The condition persists or gets worse
• A rash or allergic reaction develops

Directions

• Clean the affected area
• 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

Aloe barbadensis leaf juice, mineral oil, petrolatum

Questions

Call 1-800-200-6313

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Other Information

Store Between 15° to 25°C (59° to 77°F)

Lot No. and Expiration Date: See box and tube crimp

Distributed By:

Cardinal Health

Dublin, Ohio 43017

www.myleader.com

1-800-200-6313

Essential to Care™ Since 1979

Made in China

©2020 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.

Packaging

INGREDIENTS AND APPEARANCE

LEADER BACITRACIN ZINC 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0547
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
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0547-1	1 in 1 BOX	04/15/2020
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 final	part333B	04/15/2020

Labeler - Leader (097537435)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)