LIDOZEN- lidocaine hydrochloride, menthol patch 
Village Pharma 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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Lidozen Patch

DRUG FACTS:

ACTIVE INGREDIENTS:

Lidocaine HCL 4.00%

Menthol 1.00%

Toplcal Anesthetic

External Analgesic

USES:

For temporary relief of pain

WARNINGS:

Do not use 

in large quantities, particularly over raw surfaces or blistered areas.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

DIRECTIONS (Adults and Children Over 12 Years):

Clean and dry affected area.

Remove patch from backing and apply to affected area.

Use only one patch at a time, and maximum of four patches / day.

Leave patch on affected area for up to 8 hours.

Do not use patches for longer than five consective days.

Children under 12 should consult physician prior to use.

INACTIVE INGREDIENTS:

Propylene Glycol, Carboxymethyl Cellulose Sodium, Dihydroxyaluminum Aminoacetate, Ethanol, Glycerin, Kaolin, Partially Neutralized Polyacrylate, Polysorbate 80, Polyvinylpyrrolidone 90, Tartaric Acid, Tetrasodium Edetate, Titanium Dioxide, Hydrogenated Castor Oil, Phenoxyethanol, Urea, Water.

Store below 25 degrees Celsius. Avoid directed sunlight.

Package Labeling:

Label

LIDOZEN 
lidocaine hydrochloride, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71574-800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TARTARIC ACID (UNII: W4888I119H)  
EDETATE SODIUM (UNII: MP1J8420LU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71574-800-055 in 1 POUCH05/01/2019
11 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2019
Labeler - Village Pharma LLC (080749749)

Revised: 10/2021
Document Id: cedc18c8-49fb-5ab4-e053-2a95a90a71f2
Set id: 02da73b3-6c57-4ffb-9639-48688879f156
Version: 4
Effective Time: 20211021
 
Village Pharma LLC