Active Ingredient
Pramoxine HCI
Polymyxin B Sulfate
Bacitracin Zinc
First Aid Antibiotic Plus Burn Relief Ointment
FDA Label NDC 69396-138
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 First Aid Antibiotic Plus Burn Relief (NDC 69396-138). 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 section, purpose, otc - active ingredient, uses, warnings, do not use, 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 Section
External Analgesic
Purpose
First Aid Antibiotic
First Aid Antibiotic
First Aid Antibiotic
Otc - Active Ingredient
Neomycin Sulfate
Uses
First Aid to help prevent infection and for the temporary relief of pain or discomfort in minor cuts, scrapes and burns.
Warnings
For external Use Only
Do Not Use
Do Not use
- In the eyes
- Over large areas of the body
- If you are allergic to any of the ingredients
Ask 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
- symptoms persist for more than 1 week or clear up and occur again within a few days
Directions
Adults and children 2 years of age and older:
- Clean the affected area and dry thoroughly.
- Apply a small amount of this product , an mount equal to the surgace area of the tip of a finger) on the area 1 to 3 times daily
- May be covered with a sterile bandage
Children under 2 years old: ask a doctor
Inactive Ingredients
White Petrolatum
Questions
Call 1-888-296-9067
Storage Information
- Store at 20° to 25°C (68° to 77°F).
- See carton or tube crimp for lot number and expiration date
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
Fort Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
* Please review the disclaimer below.
