LIDOPRO PATCH- lidocaine, menthol, and methyl salicylate patch

LidoPro Patch by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Active Ingredient

Menthol .5%

Purpose

Topical Analgesic

Active Ingredient

Methyl Salicylate .1%

Purpose

Topical Counterirritant

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do not use

more than one patch on your bidy at a time or on cuts, irritated, or swollen skin

on puncture wounds

for more than one week without consulting a doctor.

When using this product

• Use only as directed. Read and follow directions and warning on this packaging.
• Do not apply to wounds or damaged, broken, or irritated skin
• Avoid contact with the eyes or mucous membranes
• Do not bandage tightly or apply local heat (such as heating pads) to area of use
• Do not use at the same time as other topical analgesics
• Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and ask a doctor if

• conditions worsens
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of injury, such as pain, swelling, or blistering where the product was applied

If pregnant orbreast feeding,

ask health professional before use.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

adults and children over 12 years:

• clean and dry the affected area
• remove patch from plastic liner and place on the affected area
• use 1 patch for up to 12 hours
• place used patch on the liner when not in use
• re-use the patch up to 2 times.

children 12 years or younger: ask a doctor

Distributed by
Advanced Rx Pharmacy of Tennessee, LLC

OTHER INGREDIENTS:

Vegan Glycerol, Polyacrylate, Aqua. Polysorbate 80

Principal Display Panel

INGREDIENTS AND APPEARANCE

LIDOPRO PATCH 
lidocaine, menthol, and methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80425-0374(NDC:83881-401)
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	0.5 mg  in 100 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.1 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80425-0374-1	15 in 1 BOX	02/29/2024
1		2 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	02/29/2024

Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)

Establishment
Name	Address	ID/FEI	Business Operations
Advanced Rx Pharmacy of Tennessee, LLC		117023142	repack(80425-0374)