Triple Antibiotic
FDA Label NDC 67510-0631

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Triple Antibiotic (NDC 67510-0631). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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

Active Ingredient

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

Do Not Use

  • If you are allergic to any of the ingredients

Directions

  • adults and children 2 years of age and older:
    • 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 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age:  ask a doctor

Other Information

  • store at 15° to 25°C (59° to 77°F)

Inactive Ingredients

Cetyl alcohol, Glycerin, Light mineral oil, Steareth-2, Stearic acid, Squalane, Tocopheryl acetate, and White petrolatum

Package Label Panel

Triple Antibiotic Ointment

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