LIDOPRO- lidocaine and menthol patch

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients (in each patch)

Lidocaine 4%

Purpose

External Anesthetic

Active ingredients (in each patch)

Menthol 1%

Purpose

External Analgesic

Use

Temporarily relieves minor pain

Warnings

For external use only

Do not use

• more than one patch on your body at a time 
• on cut, irritated or swollen skin 
• on puncture wounds 
• for more than one week without consulting a doctor 
• if you are allergic to any active or inactive ingredients 
• if pouch is damaged or opened

When using this

• use only as directed 
• read and follow all directions and warnings on this carton 
• do not allow contact with the eyes 
• do not use at the same time as other topical analgesics 
• do not bandage tightly or apply local heat (such as heating pads) to the area of use 
• do not microwave 
• 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 consult a doctor if

• condition 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 skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center 1-800-222-1222 right away.

Directions

Adults and children 12 years of age and over: clean and dry affected area, free of lotions, ointments, and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12-hour period. Maximum 2 patches per day. Discard patch after single use.
Children under 12 years of age: consult a physician.

Other information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive ingredients

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid, polysorbate 80, povidone K90, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions or comments?

Call (800) 224-2048 or email info@clinicpharma.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

LIDOPRO 
lidocaine and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80425-0582(NDC:83881-403)
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
KAOLIN (UNII: 24H4NWX5CO)
MINERAL OIL (UNII: T5L8T28FGP)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80425-0582-1	30 in 1 CARTON	04/17/2026
1		1 in 1 POUCH
1		10 g 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	04/17/2026

Labeler - Advanced Rx of Tennessee, LLC (117023142)

Establishment
Name	Address	ID/FEI	Business Operations
Advanced Rx of Tennessee, LLC		117023142	repack(80425-0582)