Bacitracin Zinc
FDA Label NDC 67777-220

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Bacitracin Zinc (NDC 67777-220). 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, warnings:, dosage & administration:, stop use and ask a doctor if, indications & usage:, keep out of reach of children, purpose:, other information, 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                                               Purpose
Bacitracin Zinc (500 Units in each gram)               First Aid Antibiotic

Warnings:

For external use only

Dosage & 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

Stop Use And Ask A Doctor If

Stop use and ask a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops.

Indications & Usage:

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

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

Purpose:

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

Other Information

  • store at controlled room temperature
  • Avoid excessive heat and humidity
  • Tamper Evident. Do not use if inner seal is torn, cut or open.

Ask A Doctor If

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Principal Display Panel

Dynarex Bacitracin Zinc Ointment:

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