Triple Antibiotic Ointment
FDA Label NDC 69396-015
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 69396-015). 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 drug facts, active ingredient (each gram contains), purpose, otc - keep out of reach of children, indications & usage, warnings, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (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
Warnings For external use only.
Do not use ● in the eyes ● over large areas of the body
● if you are allergic to any of the ingredients.
Ask a doctor before use if you have
● deep or puncture wounds ● animal bites ● serious burns.
Stop use and ask a doctor if ● condition persists or gets worse
● you need to use longer than 1 week
● a rash or other allergic reaction develops
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, Petrolatum
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
Otc - Questions
Questions? Call 1-888-296-9067
Other
Distributed by:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301, USA
www.trifecta-pharma.com
Packaging
Triple Antibiotic (T Antibiotic)
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