Active Ingredient
Bacitracin Zinc 400 Units
Neomycin Sulfate 3.5 mg
Polymyxin B Sulfate 5000 Units
Triple Antibiotic Ointment
FDA Label NDC 69396-135
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 69396-135). 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, purpose, uses, warnings, ask doctor before use if you have, do not use, stop use and ask doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antibiotic
First Aid Antibiotic
First Aid Antibiotic
Uses
First Aid to help prevent infection in minor:
- cuts
- scrapes
- burns
Warnings
For External Use Only.
Ask Doctor Before Use If You Have
deep or puncture wounds
animal bites
serious burns
Do Not Use
- in eyes
- over large areas of the body
- if you are allergic to any of the ingredients
Stop Use And Ask Doctor If
- If conidition persists or gets worse
- You need to use longer than 1 week
- A rash or allergic reaction develops
Directions
- Clean the affected area and dry thoroughly
- Apply a small amount of the 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 Ingredients
light mineral oil and white petrolatum
Questions
Call 1-888-296-9067
Storage Information
Store at 20° to 25°C (68° to 77°F).
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Other Information
Distributed By:
Trifecta Pharmaceuticals USA®
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
Reorder: R519-545
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