COLD AND HOT MEDICATED Patch

Manufacturer
Henan Enokon Medical Instrument Co., Ltd.
Effective date
2026-01-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:35:54

Label at a glance#

ProductCOLD AND HOT MEDICATED Patch
Active ingredientMENTHOL
Label structure13 sections

Dosage and administration

Adults and Children 12 years of age and older: • Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch • Should be used up to 8 hours • Should be used no more than 3 to 4 times daily Children under 12 years of age: Consult a doctor.

Storage and handling

• store at room temperature 68° to 77°F (20° to 25°C) *Compare to the active ingredient in Icy Hot® Patch EXTRA STRENGTH Contains Menthol 5% Pain relieving ointment on a breathable adhesive pad EXTRA STRENGTH COLD & HOT MEDICATED PATCH works on contact providing pain relief that lasts for hours. The thin, flexible patch is comfortable to wear and is easy to remove. FAST RELIEF OF MINOR ACHES AND PAINS *This produc...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

Temporarily relieve minor aches and pains of muscles and joints due to
• simple backache • arthritis • muscle strains • bursitis • tendonitis • muscle sprains • bruises • cramps

Warnings

WARNINGS SECTION

EXTERNAL USE ONLY

When Using

OTC - WHEN USING SECTION

• USE ONLY AS DIRECTED • do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin.

Stop Use

OTC - STOP USE SECTION

• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • skin irritation develops

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

KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 years of age and older:
• Peel off protective backing and apply sticky side to affected area. Carefully remove backing from patch
• Should be used up to 8 hours
• Should be used no more than 3 to 4 times daily
Children under 12 years of age: Consult a doctor.

Other information

STORAGE AND HANDLING SECTION

• store at room temperature 68° to 77°F (20° to 25°C)

*Compare to the active ingredient in Icy Hot® Patch

EXTRA STRENGTH

Contains Menthol 5%

Pain relieving ointment on a breathable adhesive pad

EXTRA STRENGTH COLD & HOT MEDICATED PATCH works on contact providing pain relief that lasts for hours. The thin, flexible patch is comfortable to wear and is easy to remove.

FAST RELIEF OF MINOR ACHES AND PAINS

*This product is NOT manufactured or distributed by Chattem Inc., owner of the registered trademark Icy Hot® Patch.

Distributed By:
Universal Distribution Center
96 Distribution Boulevard • Edison, NJ 08817

MADE IN CHINA

www.universaldc.com

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxy-methylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN1
420222menthol 0.05 MG/MG Medicated PatchSCD1
420222menthol 5 % Medicated PatchSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130676979826356GTIN-13: 0676979826356
EAN-13: 0676979826356
GTIN-12: 676979826356
UPC-A: 676979826356
GTIN storage (14 digits): 00676979826356
Pack.jpg, Pack2.jpg

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
83559-015-01COLD AND HOT MEDICATED Patch1 in 1 POUCHPATCH11
83559-015-01COLD AND HOT MEDICATED Patch24 in 1 BOXPATCH241

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
83559-01583559-015-01

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

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
COLD AND HOT MEDICATED PatchCOLD AND HOT MEDICATED PATCHHenan Enokon Medical Instrument Co., Ltd.49aca763-be2a-cf38-e063-6294a90a092e2026-01-31WarningsExact identifier
ndc (package): 83559-015-01
ndc (product): 83559-015
ndc11 (package): 83559001501
spl id: 49aca763-be2b-cf38-e063-6294a90a092e
spl set id: 49aca763-be2a-cf38-e063-6294a90a092e

Reported adverse events (FAERS/openFDA)#

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