Triple Antibiotic Ointment
FDA Label NDC 69103-5603

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Provision Medical for the product Triple Antibiotic (NDC 69103-5603). 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 ingredients, purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

(in each gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 5000 units)

Purpose

First aid antibiotic

Uses

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

Warnings

For external use only

Do Not Use

  • internally
  • in eyes
  • over large areas of the body or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients

Stop Use And Ask A Doctor If

  • a rash or allergic reaction develops
  • condition worsens or persists

Keep Out Of Reach Of Children

If ingested, contact a Poison Control Center right away.

Directions

  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage

Inactive Ingredient

petrolatum

Principal Display Panel – 0.5G Pouch Label

Triple Antibiotic
Ointment

The Provision
First Aid
Line™

0.5 g
(1/57 oz.)

Principal Display Panel – 0.5g Pouch Label (Pro28 0000 01)

Principal Display Panel – 0.5g Pouch Label (Pro28 0000 01)

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