BURN GEL- lidocaine hci gel

Burn Gel by

Drug Labeling and Warnings

Burn Gel by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine HCL 2%

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN GEL 
lidocaine hci gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-106-09	144 in 1 CARTON	09/27/2022
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/27/2022

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)