Bacitracin Ointment
FDA Label NDC 63187-299

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Bacitracin (NDC 63187-299). 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 and administration:, stop use and ask a doctor if, do not use:, keep out of reach of children, purpose, indications and usage, 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 500 Units                Antibiotic

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

Stop Use And Ask 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
  • in the eyes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

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
burns

Indications And Usage

Ask a doctor before use:

  • in case of deep or puncture wounds
  • animal bites
  • serious burns

Other Information

  • store at controlled room temperature 15°-30° C (59°-86° F)

Inactive Ingredients

Light Mineral Oil, White Petrolatum

Principal Display Panel

Relabeled By:

Proficient Rx LP Thousand Oaks, CA 91320

Bacitracin Ointment:

bacitracin-galentic-ointment-01.jpg

63187-299-01 (Bacitracin Galentic Ointment 01)

63187-299-01 (Bacitracin Galentic Ointment 01)

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