LIDOZEN PATCH- 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 direct sunlight.

Package Labeling:

Label3

LIDOZEN PATCH 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71574-905
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:71574-905-055 in 1 POUCH09/01/2022
11 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/01/2022
Labeler - Village Pharma LLC (080749749)

Revised: 11/2023
Document Id: 0b582aca-c4d6-93af-e063-6294a90ac526
Set id: d0ec7d25-ad58-46f2-b3b3-f13b4648b0b6
Version: 2
Effective Time: 20231129
 
Village Pharma LLC