Triple Antibiotic Ointment
FDA Label NDC 0363-1332

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Co. for the product Triple Antibiotic (NDC 0363-1332). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if you have, 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.

Active Ingredient(S)

Active Ingredient (in each gram)

Bacitracin Zinc, USP            400 units

Neomycin                             3.5mg 

Polymyxin B Sulfate, USP   5,000 units

Purpose

First aid antibiotic

Use(S)

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

Warnings

For external use only.

Do Not Use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask A Doctor Before Use If You Have

■ deep or puncture wounds

■ animal bites

■ serious burns

Stop Use And Ask A Doctor If

■ you need to use longer than one week

■ condition persists or gets worse

■ rash or other allergic reaction develops

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 to 3 times daily
■ may be covered with a sterile bandage

Other Information

■ store at 15°-30°C (59°-86°F). Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredient

white petrolatum

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