Bacitracin Zinc And Polymyxin B Sulfate
FDA Label NDC 52959-054

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H.j. Harkins Company, Inc. for the product Bacitracin Zinc And Polymyxin B Sulfate (NDC 52959-054). 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 active ingredients (in each gram), purpose, indications & usage, otc - do not use, otc - ask doctor, otc - when using, 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

Active Ingredients (In Each Gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Polymyxin B Sulfate (equal to 10,000 polymyxin B units)

Purpose

Antibiotic

Antibiotic

Indications & Usage

Uses first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burn

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 in case of deep or puncture wounds, animal bites or serious bums

Otc - When Using

When using this product do not use longer than 1 week unless directed by a doctor

Otc - Stop Use

Stop use and ask a doctor if

  • the condition persists or gets worse
  • if a 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.

Dosage & Administration

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

Other information

  • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal • store at room temperature
  • see crimp of tube for Lot No. and Exp. date

Inactive Ingredient

Inactive ingredient white petrolatum

Questions or comments ? call toll free 1-800-645-9833

Package Label – Principal Display Panel – 1/2 Oz Container

Fougera®

NDC 0168-0021-35

Double Antibiotic Ointment
(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)

Repacked by:
H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA 93444

Package Label – Principal Display Panel – 1/2 Oz Container (Double Antibiotic 01)

Package Label – Principal Display Panel – 1/2 Oz Container (Double Antibiotic 01)

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