FDA.reportPublic FDA data

Cold/Hot Medicated Patches

Manufacturer
Dynarex Corporation
Effective date
2018-11-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:11

Label at a glance#

ProductCold/Hot Medicated Patches
Active ingredientMENTHOL
Label structure10 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

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
  • symptoms 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.

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
  • wear each patch up to 8 hours maximum

Children under 12 years of age

  • consult a doctor

Other information

OTHER SAFETY INFORMATION

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aluminum Hydroxide, Castor Oil, Disodium EDTA, Glycerin, Isopropyl Myristate, Kaolin, Polysorbate, Polyvinyl Alcohol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Label NDC 67777-145-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67777-145-10NDC 67777-145-10

Label NDC 67777-145-20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67777-145-20NDC 67777-145-20

Label NDC 67777-145-30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67777-145-30NDC 67777-145-30

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67777-145-102020-01-31C16284748780-19d75b9d0-a1ad-f424-e053-dadaa90a57ce1451 - NDC 67777-145-10 1452 - NDC 67777-145-20 1453 - NDC 67777-145-30
67777-145-202020-01-31C16284748780-19d75b9d0-a1ad-f424-e053-dadaa90a57ce1451 - NDC 67777-145-10 1452 - NDC 67777-145-20 1453 - NDC 67777-145-30
67777-145-302020-01-31C16284748780-19d75b9d0-a1ad-f424-e053-dadaa90a57ce1451 - NDC 67777-145-10 1452 - NDC 67777-145-20 1453 - NDC 67777-145-30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-145-10Cold/Hot Medicated Patches180 in 1 CASEPATCH1801
67777-145-10Cold/Hot Medicated Patches5 in 1 BOXPATCH51
67777-145-20Cold/Hot Medicated Patches5 in 1 BOXPATCH51
67777-145-20Cold/Hot Medicated Patches180 in 1 CASEPATCH1801
67777-145-30Cold/Hot Medicated Patches108 in 1 CASEPATCH1081
67777-145-30Cold/Hot Medicated Patches3 in 1 BOXPATCH31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-145COLD/HOT MEDICATED PATCHES (MEDICATED PATCHES) PATCH [DYNAREX CORPORATION]1Legacy NDC, 6 package rows20181108_7a1449c9-7a44-412d-e053-2991aa0a6649.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-14567777-145-10, 67777-145-20, 67777-145-30

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
EDETATE DISODIUM7FLD91C86KIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POLYSORBATE 806OZP39ZG8HIACT
TARTARIC ACIDW4888I119HIACT
GLYCERINPDC6A3C0OXIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
CASTOR OILD5340Y2I9GIACT
KAOLIN24H4NWX5COIACT

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
7a1449c9-7a45-412d-e053-2991aa0a66497a1449c9-7a44-412d-e053-2991aa0a66492018-11-07WarningsExact identifier
spl id: 7a1449c9-7a45-412d-e053-2991aa0a6649
spl set id: 7a1449c9-7a44-412d-e053-2991aa0a6649

Reported adverse events (FAERS/openFDA)#

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