LIDOPRO PATCH- lidocaine and menthol patch

LidoPro Patch by

Drug Labeling and Warnings

LidoPro Patch by is a Otc medication manufactured, distributed, or labeled by Advanced Rx of Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

LIDOPRO PATCH 
lidocaine and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80425-0438(NDC:53225-1123)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 mg  in 100 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80425-0438-1	6 in 1 BOX	09/09/2024
1		5 in 1 POUCH
1		8500 mg in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/09/2024

Labeler - Advanced Rx of Tennessee, LLC (117023142)

Establishment
Name	Address	ID/FEI	Business Operations
Advanced Rx of Tennessee, LLC		117023142	repack(80425-0438)