FDA Label for Bacitracin Zinc, Neomycin Sulfate And Polymyxin B Sulfate

View Indications, Usage & Precautions

Bacitracin Zinc, Neomycin Sulfate And Polymyxin B Sulfate Product Label

The following document was submitted to the FDA by the labeler of this product Galentic Pharma (india) Private Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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