Active Ingredient
Lidocaine HCI 2.0%
Burn Relief Spray
FDA Label NDC 69396-107
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 Burn Relief (NDC 69396-107). 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, indications & usage, warnings, stop use and ask a doctor, keep out of the reach of children, do not use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Pain Relief
Indications & Usage
Temporary pain relief associated with minor burns.
Warnings
For External Use Only
Stop Use And Ask A Doctor
- If the condition worsens or persists for more than 7 days or clears up and returns.
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use
- In large quantities, particularly over raw or blistered areas
- Near eyes, if this happens rinse throughly with water
Directions
- Spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily.
- Not to be used on children under 12 years of age.
Other Information
- Store at controlled room temperature 68°-77°F (20°-25°C)
Inactive Ingredients
Glycerin, hydroxypropyl methylcellulose, melaleuca alternifilia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol propylene glycol, triethanolamine, water
Questions Or Comments
Call 1-888-296-9067
Distributed By:
Trifecta Pharmaceuticals USA, LLC.
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
SKU: 4049
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