Hot Cold Medicated Patches

Manufacturer
Henan Enokon Medical Instrument Co., Ltd. | Henan Enokon Medical Instrument Co Ltd.
Effective date
2025-04-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:58:30

Label at a glance#

ProductHot Cold Medicated Patches
Active ingredientMENTHOL
Label structure14 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

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Use

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints associated with:■simple backache■arthritis■ strains■bruises ■sprains

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

■ 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

When using this product
■ use only as directed
■ avoid contact with the eyes mucous membranes or rashes ■ do not bandage tightly

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if
■ 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 Out 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, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions

OTC - QUESTIONS SECTION

Call 718-975-2586

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN2
420222menthol 0.05 MG/MG Medicated PatchSCD2
420222menthol 5 % Medicated PatchSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83559-003-01Hot Cold Medicated Patches2 in 1 BAGPATCH22
83559-003-02Hot Cold Medicated Patches1 in 1 BAGPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83559-003HOT COLD MEDICATED PATCHES PATCH [HENAN ENOKON MEDICAL INSTRUMENT CO., LTD.]2Current NDC, 2 package rows20250406_159266a8-94fa-e2ff-e063-6394a90a9a77.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83559-00383559-003-01, 83559-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-04-08full-release2026-06-01 00:10:48

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
Hot Cold Medicated PatchesHOT COLD MEDICATED PATCHESHenan Enokon Medical Instrument Co., Ltd.159266a8-94fa-e2ff-e063-6394a90a9a772025-04-02WarningsExact identifier
ndc (package): 83559-003-02
ndc (package): 83559-003-01
ndc (product): 83559-003
ndc11 (package): 83559000301
ndc11 (package): 83559000302
spl id: 31c6f5d1-443f-e9ec-e063-6294a90a716b
spl set id: 159266a8-94fa-e2ff-e063-6394a90a9a77

Reported adverse events (FAERS/openFDA)#

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