Leader Poly Bacitracin Ointment

Leader Poly Bacitracin Ointment
SPL v1
SPL
SPL Set ID 20d7624f-cafa-25e1-e063-6394a90a4439
Route
TOPICAL
Published
Effective Date 2024-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U]) Polymyxin B (10000 [USP'U])
Inactive Ingredients
Mineral Oil White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-15

Description

Bacitracin Zinc 500 Units per gram

Purpose

First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 500 Units per gram

Uses

First Aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns
Warnings

For External Use Only.

Packaging

Questions

Call 1-888-296-9067

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
Do Not Use
  • in eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
Acrive Ingredient

Polymixin B Sulfate 10,000 Units Per gram

Active Ingredient

Bacitracin Zinc 500 Units per gram

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.

Inactive Ingredients

mineral oil, white petrolatum

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
Keep Out of Reach of Children

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

Ask Doctor Before Use If You Have

deep puncture wounds.

animal bites

serious burns.


Structured Label Content

Uses

First Aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns
Purpose

First Aid Antibiotic

Warnings

For External Use Only.

Packaging

Questions

Call 1-888-296-9067

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
Do Not Use
  • in eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
Acrive Ingredient

Polymixin B Sulfate 10,000 Units Per gram

Active Ingredient

Bacitracin Zinc 500 Units per gram

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.

Inactive Ingredients

mineral oil, white petrolatum

Stop Use and Ask Doctor If (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
Keep Out of Reach of Children (Keep out of reach of children)

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

Ask Doctor Before Use If You Have (Ask Doctor before Use if you have)

deep puncture wounds.

animal bites

serious burns.


Advanced Ingredient Data


Raw Label Data

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