Triple Antibiotic Ointment
FDA Label NDC 69396-125

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Triple Antibiotic (NDC 69396-125). 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 (each gram contains), purpose, otc - keep out of reach of children, indications & usage, warnings, ask doctor before use, do not use, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (Each Gram Contains)

Bacitracin zinc 400 units
Neomycin sulfate 3.5 mg 
Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic

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.

Indications & Usage

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

Warnings

For external use only.

Directions

● clean the affected area and dry thoroughly.

● 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.

Inactive Ingredient

Inactive ingredient light Mineral Oil, White Petrolatum

Other Information


● store at 20° to 25°C ( 68° to 77°F)

Otc - Questions

Questions? Call 1-760-642-2638

* Please review the disclaimer below.