Leader Poly Bacitracin Ointment
FDA Label NDC 70000-0093

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Inc. for the product Leader Poly Bacitracin (NDC 70000-0093). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients (in each gram), purpose, uses, warnings, allergy alert:, do not use, consult a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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

Otc - Keep Out Of Reach Of Children

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 20°-25°C (68° to 77°F)

Inactive Ingredient

Petrolatum

Package Label.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 – 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) 

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