Triple Antibiotic Ointment
FDA Label NDC 63187-623

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Triple Antibiotic (NDC 63187-623). 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 (in each gram), purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Gram)

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

Purpose

First aid antibiotic

Uses

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
• longer than 1 week unless directed by a doctor

Ask a doctor before use if you have
• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if  
• the 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 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 room temperature

Inactive Ingredient

light mineral oil, white petrolatum

Package Label.Principal Display Panel

Triple Antibiotic Ointment
FIRST AID ANTIBIOTIC OINTMENT
Polymyxin B Sulfate, Bacitracin Zinc, Neomycin Sulfate
Net Wt. 1 oz (28.4 g)

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