FDA.reportPublic FDA data

Hot/Cold Medicated Patch

Manufacturer
Dynarex
Effective date
2025-03-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:57:22

Label at a glance#

ProductHot/Cold Medicated Patch
Active ingredientMENTHOL
Label structure11 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 Wear each patch up to 8 hours maximum Children under 12 years of age, consult a doctor

Storage and handling

Avoid storing product in direct sunlight Protect product from excessive moisture

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 due to

  • Arthritis
  • Simple backache
  • Strains
  • Sprains
  • Bruises

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 are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Excessive redness or irritation is present
  • Conditions worsen
  • Symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 (1-800-222-1222) 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
  • Wear each patch up to 8 hours maximum

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Castor Oil, Dihydroxyaluminum Aminoacetate, Disodium Edetate Dihydrate, Glycerol, Isopropyl Myristate, Polyacrylic Acid (250000 MW), Polysorbate 80, Polyvinyl Alcohol, Propylene Glycol, Silicon Dioxide, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Urea, Water

Questions and Comments?

OTC - QUESTIONS SECTION

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1450_BX_MASTER1450_BX_MASTERCold Hot Medicated Patch 1450

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1451_IN_MASTER1451_IN_MASTERCold Hot Medicated Patch 1451

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1452_IN_MASTER1452_IN_MASTERCold Hot Medicated Patch 1452

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN5
420222menthol 0.05 MG/MG Medicated PatchSCD5
420222menthol 5 % Medicated PatchSY5

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
67777-201-08Hot/Cold Medicated Patch36 in 1 CASEPATCH365
67777-201-09Hot/Cold Medicated Patch285 mg in 1 PATCHPATCH2855
67777-201-09Hot/Cold Medicated Patch3 in 1 BAGPATCH35
67777-201-10Hot/Cold Medicated Patch36 in 1 CASEPATCH365
67777-201-11Hot/Cold Medicated Patch5 in 1 BOXPATCH55
67777-201-11Hot/Cold Medicated Patch285 mg in 1 PATCHPATCH2855
67777-201-20Hot/Cold Medicated Patch36 in 1 CASEPATCH365
67777-201-21Hot/Cold Medicated Patch285 mg in 1 PATCHPATCH2855
67777-201-21Hot/Cold Medicated Patch5 in 1 BOXPATCH55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-201HOT/COLD MEDICATED PATCH (HOT COLD PATCH) PATCH [DYNAREX]5Current NDC, Legacy NDC, 9 package rows20250321_999881b3-287e-d975-e053-2995a90a87e3.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-20167777-201-11, 67777-201-10, 67777-201-21, 67777-201-20, 67777-201-09, 67777-201-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
CASTOR OILD5340Y2I9GIACT
POLYSORBATE 806OZP39ZG8HIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AACTIB
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
UREA8W8T17847WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML · Source PDF

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 PatchHOT COLD PATCHDynarex999881b3-287e-d975-e053-2995a90a87e32025-03-14WarningsExact identifier
ndc (package): 67777-201-11
ndc (package): 67777-201-20
ndc (package): 67777-201-08
ndc (package): 67777-201-09
ndc (package): 67777-201-21
ndc (package): 67777-201-10
ndc (product): 67777-201
ndc11 (package): 67777020120
ndc11 (package): 67777020111
ndc11 (package): 67777020109
ndc11 (package): 67777020108
ndc11 (package): 67777020121
ndc11 (package): 67777020110
spl id: 304db1ab-acd9-43d5-e063-6294a90aeec2
spl set id: 999881b3-287e-d975-e053-2995a90a87e3

Reported adverse events (FAERS/openFDA)#

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