First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate Gel
FDA Label NDC 84219-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by M-star (hubei) Health&care Products Co., Ltd. for the product First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate (NDC 84219-001). 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 drug facts, active ingredients (in each gram), purpose, use, warnings:, do not use, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients (In Each Gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

First aid antibiotic

Use

  • First aid to help prevent infection in minor cuts,scrapes and burns.

Warnings:

For external use only. 

Do Not Use

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

Ask A Doctor Before Use If You Have

  • deep or puncture wounds 
  • animal bites 
  • serious burns

Stop Use And Ask A Doctor If

  • the condition persists or gets worse.
  • a rash or other allergic reaction develops.

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:

Store at room temperature

Inactive Ingredient:

Mineral oil, petrolatum, purified water

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Package Labelling:

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