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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Urgent First Aid Burn Cream

Active Ingredient

Lidocaine HCI 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

To reorder:

Call 1-760-642-2638

Storage Information

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Other Information

Manufactured for:

Urgent First Aid®

2603 Industry Street

Oceanside, CA. 92054 USA

www.UrgentFirstAid.com

Reorder # URG-400

URG-400 BURN CREAM 0.9G 25PK 032023 CDER

BURN CREAM 
benzalkonium chloride, lidocaine hci cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-124
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
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TROLAMINE (UNII: 9O3K93S3TK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MINERAL OIL (UNII: T5L8T28FGP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-124-0925 in 1 CARTON03/02/2023
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 not finalpart34803/02/2023
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 7/2023
Document Id: 00b82ca7-a3b0-f359-e063-6394a90a82a8
Set id: fe439c60-5a02-648f-e053-6294a90a1403
Version: 2
Effective Time: 20230717
 
Trifecta Pharmaceuticals USA LLC