ThermaPatch (TM) Lidocaine Pain Relief Patch

Manufacturer
Henan Enokon Medical Instrument Co., Ltd.
Effective date
2024-11-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:36:27

Label at a glance#

ProductThermaPatch (TM) Lidocaine Pain Relief Patch
Active ingredientLIDOCAINE
Label structure13 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Use

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

Stop Use

OTC - STOP USE SECTION

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

OTC - ASK DOCTOR SECTION

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

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1
1737778lidocaine 4 % Medicated PatchSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83559-006-01ThermaPatch (TM) Lidocaine Pain Relief Patch6 in 1 BOXPATCH61
83559-006-01ThermaPatch (TM) Lidocaine Pain Relief Patch1 in 1 PATCHPATCH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83559-006THERMAPATCH (TM) LIDOCAINE PAIN RELIEF PATCH (LIDOCAINE PAIN RELIEF PATCH) PATCH [HENAN ENOKON MEDICAL INSTRUMENT CO., LTD.]1Current NDC, 2 package rows20241110_26769590-cd50-1b01-e063-6394a90a445c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83559-00683559-006-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ThermaPatch (TM) Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.26769590-cd50-1b01-e063-6394a90a445c2024-11-09WarningsExact identifier
ndc (package): 83559-006-01
ndc (product): 83559-006
ndc11 (package): 83559000601
spl id: 26769590-cd51-1b01-e063-6394a90a445c
spl set id: 26769590-cd50-1b01-e063-6394a90a445c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.