Active Ingredient
Lidocaine HCL 2%
Burn Gel
FDA Label NDC 69396-106
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 Gel (NDC 69396-106). 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, directions, inactive ingredients, questions?, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Pain Relief
Uses
Temporary pain relief for minor burns. For professional use only.
Warnings
For external Use Only
Do not use
- in large quantities, particularly over raw or blistered areas
- near eyes, if this happens rinse thoroughly with water
Directions
Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
Children under 2 years: do not use, consult a doctor
Inactive Ingredients
Aloe barbadensis leaf juice, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Phenoxyethanol, Propylene glycol, purified water, Triethanolamine, Vitamin E acetate
Questions?
Call 1-888-296-9067
Stop Use And Ask A Doctor If
The condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
Storage Information
- Store at room temperature (do not freeze)
- do not use any opened or torn packets
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 Ave. Ste 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
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