Bacitracin
FDA Label NDC 54868-3269

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Bacitracin (NDC 54868-3269). 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, purpose, indications, warnings, stop use and consult a doctor, directions, inactive ingredients, storage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Indications

→ Warnings

→ Stop Use And Consult A Doctor

→ Directions

→ Inactive Ingredients

→ Storage

→ Principal Display Panel

Active Ingredient

Bacitracin 500 units per gram.

Purpose

First aid antibiotic.

Indications

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

Warnings

For external use only. Do not use in the eyes or apply over large areas of the body. In case of deep puncture wounds, animal bites, or serious burns, consult a doctor.

Stop Use And Consult A Doctor

if the condition persists or gets worse, or if a rash or other allergic reaction develops. Do not use if you are allergic to any of the ingredients. Do not use longer than one week unless directed by a doctor.

Directions

After gentle washing, apply a small amount (an amount equal to the surface area of the tip of a finger) directly to the affected areas and cover with sterile gauze if desired. May be applied 1 to 3 times daily as the condition indicates.

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