BURN CREAM- benzalkonium chloride, lidocaine hci cream 
Trifecta Pharmaceuticals USA LLC

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Globe First Aid Burn Cream

Active Ingredient

Lidocaine HCL 0.5%

Purpose

Topical Analgesic

Benzalkonium Chloride 0.13%

Purpose

First Aid Antiseptic

Uses

Temporary Relief of pain associated with minor cuts, scrapes and burns.

Helps protect against harmful bacteria.

Warnings

For external Use Only

Do not use

Directions

Inactive Ingredients

Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, glycerin, Glyceryl Stearate/PEG-100 stearate, maltodextrin, Mineral oil, Phenoxyethanol, propylene glycol, purified water, stearic acid, triethanolamine.

Questions

Call: 1-888-296-9067

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

R519-541 GLOBE FIRST AID BURN CREAM 0.9G 25PK 112823 CDER

R519-539 GLOBE FIRST AID BURN CREAM 0.9G 10CT 112823 CDER

BURN CREAM 
benzalkonium chloride, lidocaine hci cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-146
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.005 g  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-146-1010 in 1 CARTON03/06/2024
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:69396-146-2525 in 1 CARTON03/06/2024
20.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00303/06/2024
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 3/2024
Document Id: 130896d1-aaca-5932-e063-6394a90aba9f
Set id: 1308ce91-2858-310a-e063-6394a90a6810
Version: 1
Effective Time: 20240306
 
Trifecta Pharmaceuticals USA LLC