Poly Bacitracin
FDA Label NDC 52426-420

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Phoenix Global Supply Group, Inc for the product Poly Bacitracin (NDC 52426-420). 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, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Phoenix Global Supply Group, Inc.
White Plains, NY 10604

Otc - Purpose

Active ingredients (each gram contains) Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic

Uses

first aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

Warnings

For external use only

Otc - Do Not Use

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients

Otc - Ask Doctor

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - Stop Use

Stop use and ask a doctor if

  • condition persists or gets worse
  • you need to use longer than 1 week
  • rash or other allergic reaction develops

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Other Information

  • To open: unscrew cap, pull tab to remove foil seal.
  • store at 20°-25°C (68°-77°F)
  • See carton or tube crimp for lot number and expiration date.

Inactive Ingredient

white petrolatum

Questions?

Call 1-877-745-6888

Principal Display Panel - 28.4 G Tube Carton

Poly Bacitracin
Bacitracin Zinc • Polymyxin B Sulfate

First Aid Antibiotic Ointment

NDC 52426-420-06

NET WT 1 oz (28.4 g)

Principal Display Panel (28.4 g Tube Carton)

Principal Display Panel (28.4 g Tube Carton)

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