Triple Antibiotic
FDA Label NDC 68788-9811

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals, Inc for the product Triple Antibiotic (NDC 68788-9811). 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, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, 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, USP 400 units

Neomycin sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 5,000 units

Purpose

First aid antibiotic

Uses

Helps prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

For external  use only

Allergy alert:

  • do not use if allergic to any of the ingredients

Do Not Use

  • 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

When Using This Product

  • do not use longer than 1 week unless directed by a doctor

Stop Use And Ask A Doctor If

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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • clean affected area
  • apply a small 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 controlled room temperature 59° - 86°F (15° - 30°C).
  • Protect from freezing.

Inactive Ingredient

White petrolatum

How Supplied

Triple Antibiotic Ointment comes in 28gr tubes

NDC - 68788-9811-2

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Relabeled By Preferred Pharmaceuticals, Inc

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