LIDOSPOT PATCH- lidocaine and menthol patch

Lidospot patch by

Drug Labeling and Warnings

Lidospot patch by is a Otc medication manufactured, distributed, or labeled by Fabrication Enterprises Inc , Shanghai Chuangshi Medical Technology (Group) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4% w/w ...... Purpose: Topical anesthetic

Menthol 1% w/w ...... Purpose: Topical analgesic

Purposes

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

Uses

Temporarily relieves minor pain.

Warnings

For external use only

When using this product:

• Use only as directed
• Read and follow all directions and warnings on this carton
• Do not alow 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 stil containthe drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Do not use:

• More than 1 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
• lf you are allergic to any active or inactive ingredients
• lf pouch is damaged or opened.

Stop use and ask a doctor if:

Condition worsens

Redness is present

lrritation develops

Symptoms persist for more than 7 days or clear up and occur again within a few days

You experiencesigns of skin injury such as pain, swelling or blistering where the product was applied.

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

Adult and Children 12 years of age and over:

• Clean and dry affected area Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours.

Children under 12 years of age:consult a physician.

Inactive Ingredients

Dihydroxyaluminium Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin,L(+)-Tartaric Acid,Mineral oil,Polysorbate 80, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide,Water,

Questions or Comments

1-800-431-2830

Other information

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

Package label. Principal display panel

INGREDIENTS AND APPEARANCE

LIDOSPOT PATCH 
lidocaine and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51452-172
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
KAOLIN (UNII: 24H4NWX5CO)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POVIDONE K90 (UNII: RDH86HJV5Z)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51452-172-05	5 in 1 BOX	07/21/2025
1	NDC: 51452-172-01	12 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	07/21/2025

Labeler - Fabrication Enterprises Inc  (070577218)

Registrant - Fabrication Enterprises Inc  (070577218)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture(51452-172)