Triple Antibiotic Ointment
FDA Label NDC 54473-291

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Triple Antibiotic (NDC 54473-291). 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, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients (each gram contains:)
Bacitracin zinc 500 units
Neomycin 3.5 mg
Polymyxin B sulfate 10,000 units

Otc - Purpose

Purpose
antibiotic

Indications & Usage

Uses
First aid to help prevent the risk of infection in minor

  • cuts
  • scrapes
  • burns

Warnings

Warnings
For external use only.

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

Ask a doctor
before use in case of deep or puncture wounds, animal bites, or serious burns

Otc - Stop Use

Stop use and ask a doctor if

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

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 1-3 times daily
  • may be covered with a sterile bandage

Inactive Ingredient

Inactive ingredients:  Melaleuca Oil (T36-C5 (R)), mineral oil, petrolatum

Package Label.Principal Display Panel

Image Of Label (Taolabel)

Image Of Label (Taolabel)

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