THERMAPATCH (TM) LIDOCAINE PAIN RELIEF PATCH- lidocaine pain relief patch patch

ThermaPatch (TM) Lidocaine Pain Relief Patch by

Drug Labeling and Warnings

ThermaPatch (TM) Lidocaine Pain Relief Patch by is a Otc medication manufactured, distributed, or labeled by Henan Enokon Medical Instrument Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Use

For temporary relief of pain

Warnings

For external use only

Do not use

More than 1 patch at a time
On wounds or damaged skin
With a heating pad
If you have ever had an allergic reaction to this product or any of its ingredients

When Using

Use only as directed
Avoid contact with the eyes, mucous membranes or rashes
Do not bandage tightly

Stop Use

Localized skin reactions occur, such as rash, itching, redness, irritation, pain swelling, and blistering
Conditions worsen
Symptoms persist for more than 7 days
Symptoms clear up and occur again within a few days

Ask Doctor

If pregnant or breast-feeding, ask a health professional before use

Keep Oot Of Reach Of Children

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

Directions

Adults and children 12 years of age and over:
Clean and dry affected area
Remove film from patch and apply to the skin
Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
Remove patch from the skin after at most 8 hours of application
Children under 12 years of age: consult a doctor

Other information

Avoid storing product in direct sunlight
Protect product from excessive moisture
Store at 20-25°C (68-77°F)

Inactive ingredients

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Kaolin, Phenoxyethanol, Polyvinylpyrrolidone, Propylene Glycol,
Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERMAPATCH (TM) LIDOCAINE PAIN RELIEF PATCH 
lidocaine pain relief patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83559-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM GLYCINATE (UNII: 1K713C615K)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TARTARIC ACID (UNII: W4888I119H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
KAOLIN (UNII: 24H4NWX5CO)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POVIDONE (UNII: FZ989GH94E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83559-006-01	6 in 1 BOX	11/09/2024
1		1 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	11/09/2024

Labeler - Henan Enokon Medical Instrument Co., Ltd. (701730676)

Establishment
Name	Address	ID/FEI	Business Operations
Henan Enokon Medical Instrument Co., Ltd.		701730676	manufacture(83559-006)