Bacitracin Zinc
FDA Label NDC 58988-0031

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Promex, Llc for the product Bacitracin Zinc (NDC 58988-0031). 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 ingredient (in each gram), purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, 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

Active Ingredient (In Each Gram)

Bacitracin Zinc 500 units

Purpose

First aid antibiotic

Uses

 First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • 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

Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • animal bites

When Using This Product

  • do not use longer than 1 week unless directed by a doctor

Stop Use And Ask A Doctor If

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

Keep Out Of Reach Of Children

In case of accidental Ingestion, seek professional assistance or contact a Poison Control Center immediately.

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 20 - 25C (68 - 77F)

Inactive Ingredients

light mineral oil, white petrolatum

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