LIDOZEN- lidocaine, menthol patch 
Village Pharma, LLC

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Lidozen Patch

DRUG FACTS:

ACTIVE INGREDIENTS:

Lidocaine 4.00%

Menthol 1.00%

Topical 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 consecutive days,

Children under 12 should consult physician prior to use.

INACTIVE INGREDIENTS:

Water, Glycerol, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben

Store below 25 degrees Celsius, Avoid directe sunlight.

Package Labeling:

Label

LIDOZEN 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71574-900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TARTARIC ACID (UNII: W4888I119H)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71574-900-055 in 1 POUCH09/25/2019
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 DrugM01709/16/2019
Labeler - Village Pharma, LLC (080749749)

Revised: 11/2023
Document Id: 0b581dc2-c9a7-4792-e063-6394a90a7db3
Set id: 00171d6f-a0a7-4e90-abde-6dd3f1285ec0
Version: 3
Effective Time: 20231129
 
Village Pharma, LLC