Active Ingredient
Bacitracin 500 Units
Neomycin 3.5mg
Polymyxin B 10,000 Units
Pramoxine HCL 10mg
Tripleantibioticointmentandpainrelief Ointment
FDA Label NDC 69396-030
12 label sections · Submitted to the FDA by Trifecta Pharmaceuticals Usa · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa for the product Tripleantibioticointmentandpainrelief (NDC 69396-030). 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 a doctor before use, stop use and ask a doctor if:, keep out of reach of children, 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
External Analgesic
Uses
First Aid to help prevent infection in minor:
- Cuts
- Scrapes
- Burns
Warnings
For external use only. Do not use:
- In eyes
- Over large areas of the body
- If you are allergic to any of the ingredients
Ask A Doctor Before Use
Ask Doctor before use if you have:
- Deep or puncture wouns
- 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
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
- 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:
Light mineral oil, Petrolatum
Questions?
Call 1-888-296-9067
Distributed By:
Trifecta Pharmaceuticals USA ®
101 NE Third Avenue, Suite 1500
Fort Lauderdale, FL. 33301 USA
Product of PRC
www.trifecta-pharma.com
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