MEDI-FIRST- benzalkonium chloride, lidocaine cream 
Orazen Inc

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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MEDI-FIRST
Burn cream with Lidocaine

Active ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCI 0.5%

Purpose

First aid antiseptic

Topical analgesic

Uses

Warnings

For external use only.

Do not use

Stop use and ask a doctor if

Keep out of reach of children.

If ingested, get medical help or contact a Poison Control Center right away.

Directions

(continued on next panel)

Other information

Inactive ingredients

aloe barbadensis leaf juice, cetearyl alcohol,disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, maltodextrin, propylene glycol, purified water, PEG-100 stearate,phenoxyethanol, stearic acid, triethanolamine

Questions or comments?

800-634-7680

Package Label - Principal Display Panel

image of pouch label

image of box label

MEDI-FIRST 
benzalkonium chloride, lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71927-019-0225 in 1 BOX02/20/2023
1NDC:71927-019-010.9 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/20/2023
Labeler - Orazen Inc (080916640)

Revised: 2/2023
Document Id: f508434f-5949-7134-e053-2a95a90a03d7
Set id: f508434f-5948-7134-e053-2a95a90a03d7
Version: 1
Effective Time: 20230219
 
Orazen Inc