Bacitracin Zinc
FDA Label NDC 61767-220

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blossom Pharmaceuticals for the product Bacitracin Zinc (NDC 61767-220). 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, indications & usage, keep out of reach of children, purpose:, ask a doctor before use:, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredient                         Purpose
Bacitracin Zinc 500 Units                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

Indications & Usage

  • 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

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

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)

Stop Use And Ask A Doctor If

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

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Principal Display Panel

Blossom Pharmaceuticals Bacitracin Zinc Ointment:

bacitracin zinc.jpg


* Please review the disclaimer below.