LIDOPRO PATCH- lidocaine and menthol patch 
Advanced Rx Pharmacy of Tennessee, LLC

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LidoPro Patch

Drug Facts

Active Ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Active Ingredient

Menthol 1%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain.

Warnings

For external use only

Do not use

• on the face or rashes, on wounds or damaged skin

• in the eyes, mouth, or other mucous membranes

• on genitals

• with a heating pad

• right before or after heart surgery

• any patch from a pouch that has been opened for 7 or more days

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

• if tamper-evident seal is torn, broken, or missing

• more than 2 patches per day unless directed by a doctor

• children under 18 years of age

Ask a doctor before use if you have

• allergies to topical products

• high blood pressure, heart disease, or kidney disease.

When using this product

• avoid contact with eyes. If eye contact occurs, rinse thoroughly with water

• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop use and consult a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant orbreast feeding, ask a health professional before use.

Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

If put in mouth, seek medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together.

Directions

Adults 18 years and older:

• clean and dry affected area

• open pouch and remove one patch

• remove protective film from patch

• apply one patch to the affected area of pain and leave in place for 8 to 12 hours

• if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours

• only use one patch at a time

• wash hands with soap and water after applying or removing patch

• reseal pouch containing unused patches after each use

Other information

• some individuals may not experience pain relief until several minutes or hours after applying the patch

• avoid storing product in direct sunlight

• protect product from excessive moisture

• store at 67-77°F (19-25°C)

Inactive Ingredients

dihydroxyaluminum aminoacetate, glycerol, methylparaben, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, water

Questions?

877-985-8377

Principal Display Panel

LidoPro Patch

LIDOPRO PATCH 
lidocaine and menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80425-0380(NDC:53225-1123)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg  in 100 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
TARTARIC ACID (UNII: W4888I119H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80425-0380-13 in 1 BOX04/02/2024
15 in 1 POUCH
18500 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/02/2024
Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
Establishment
NameAddressID/FEIBusiness Operations
Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0380)

Revised: 4/2024
Document Id: 151e19d0-6553-092c-e063-6294a90a1d3e
Set id: 151ec070-be7f-204f-e063-6394a90a9498
Version: 1
Effective Time: 20240402
 
Advanced Rx Pharmacy of Tennessee, LLC