Triple Antibiotic
FDA Label NDC 63868-459

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Triple Antibiotic (NDC 63868-459). 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, indications & usage, warnings, do not use, stop use and ask a doctor if, ask doctor before use if you have, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients (Each Gram Contains)

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

Purpose

First Aid Antibiotic Ointment

Indications & Usage

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

Warnings

Warnings For external use only.

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.

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.

Other Information

● To open: unscrew cap, pull tab to remove foil seal

● store at 20° to 25°C ( 68° to 77°F)

● see carton or tube crimp for lot number and expiration date.

Inactive Ingredient

Inactive ingredientMineral Oil, Petrolatum

Other

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