Tribiotic Ointment
FDA Label NDC 50332-0032

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hart Health for the product Tribiotic (NDC 50332-0032). 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, adverse reactions, otc - do not use, otc - ask doctor, otc - stop use, 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 (in each gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (equivalent to 3.5mg neomycin base)

Polymyxin B Sulfate 5,000 units

Otc - Purpose

Purpose:

Topical Antibiotic

Topical Antibiotic

Topical Antibiotic

Indications & Usage

Uses: First aid to help prevent infection and temporarily relieve pain in
  • minor cuts
  • scrapes
  • burns
  • abrasions

Warnings

Warnings: For external use only

Serious burns require immediate medical attention


Adverse Reactions

Allergy alert: Do not use if you are allergic to any of the ingredients

Otc - Do Not Use

do not use

  • in or near the eyes
  • over large portions of the body
  • longer than 7 days unless directed by a doctor
  • more than 1 to 3 times daily

Otc - Ask Doctor

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens or lasts for more than 7 days
  • a rash or other allergic reaction occurs

Otc - 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.

Dosage & Administration

Directions:

Do not use more than directed.

Adults and children 12 years of age and over:

  • clean the affected area
  • apply 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

    • Children under 12 years of age: ask a doctor

Inactive Ingredient

Petrolatum

Package Label.Principal Display Panel

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Tribiotic5.jpg (Tribiotic5)

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