BURN GEL- lidocaine hci gel 
Trifecta Pharmaceuticals USA LLC

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Globe First Aid Burn Gel

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

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

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

4048 Globe Burn Gel 0.9g CDER

BURN GEL 
lidocaine hci gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
.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)  
TROLAMINE (UNII: 9O3K93S3TK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-106-09144 in 1 CARTON09/27/2022
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/27/2022
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 1/2024
Document Id: 0df86c68-116e-515e-e063-6294a90a416a
Set id: e9d3e9be-1036-fad0-e053-2a95a90a6efe
Version: 2
Effective Time: 20240102
 
Trifecta Pharmaceuticals USA LLC