LIDOZEN- lidocaine, menthol patch 
Proficient Rx LP

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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:

For external use only.
Avoid contact with eyes.
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

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:

71205-348-30
LIDOZEN 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-348(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, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 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:71205-348-055 in 1 BOX08/24/2021
11 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:71205-348-1515 in 1 BOX08/24/2021
21 g in 1 PATCH; Type 0: Not a Combination Product
3NDC:71205-348-3030 in 1 BOX11/01/2019
31 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 - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-348) , RELABEL(71205-348)

Revised: 12/2023
Document Id: f687fe54-1e59-45c2-859f-cb3279ed259d
Set id: 488d665c-a4fe-4a69-bab3-34b2347f4b05
Version: 6
Effective Time: 20231201
 
Proficient Rx LP