Active Ingredients (Each Gram Contains)
Bacitracin zinc 400 units
Neomycin sulfate 3.5 mg
Polymyxin B sulfate 5,000 units
Triple Antibiotic Ointment
FDA Label NDC 69396-131
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 69396-131). 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, keep out of reach of children, uses, warnings, directions, stop use and ask doctor, ask doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First aid antibiotic
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
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.
Stop Use And Ask Doctor
- Condition persists or gets worse
- You need to use longer than 1 week
- A rash or other allergic reaction develops
Ask Doctor Before Use If You Have
- Deep or puncture wounds
- Animal Bites
- Serious Burns
Do Not Use
- In the eyes
- Over large areas of the body
- If you are allergic to any of the ingredients
Inactive Ingredient
Inactive ingredient light Mineral Oil, Petrolatum
Other Information
● 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 1-800-883-0085
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For Product Information please visit: bestchoicebrands.com/58314
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