FDA Label for Burn Relief
View Indications, Usage & Precautions
Burn Relief Product Label
The following document was submitted to the FDA by the labeler of this product Trifecta Pharmaceuticals Usa, Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Lidocaine HCI 2.0%
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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