Bacitracin Zinc, Neomycin Sulfate And Polymyxin B Sulfate
FDA Label NDC 50382-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Galentic Pharma (india) Private Limited for the product Bacitracin Zinc, Neomycin Sulfate And Polymyxin B Sulfate (NDC 50382-008). 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 otc - active ingredient, purpose:, indications and usage:, other information, inactive ingredients:, keep out of reach of children, warnings, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in ea. gram)                                                Purpose
Bacitracin Zinc 400 Units                                                          First Aid Antibiotic

Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)              First Aid Antibiotic

Polymyxin B Sulfate 5000 Units                                                 First Aid Antibiotic

Purpose:

First aid to help prevent infection in:

  • Minor cuts
  • scrapes
  • burns

Indications And Usage:

  • in case of deep or puncture wounds
  • animal bites
  • serious burns

Other Information

  • store at controlled room temperature 15°-30° C (59°-86° F)
  • avoid excessive heat and humidity

Inactive Ingredients:

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Warnings

For external use only

Dosage And Administration

  • clean the affected areas
  • apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Do Not Use:

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Stop Use And Ask A Doctor If

  • Stop use and ask a doctor if condition persists or gets worse, or if a rash or other allergic reaction occurs

Principal Display Panel

Galentic Triple Antibiotic Ointment

Gal Triple.jpg

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