FDA.reportPublic FDA data

Cold and Hot Medicated

Manufacturer
The Mentholatum Company | Teikoku Seiyaku Co., Ltd.
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:43:21

Label at a glance#

ProductCold and Hot Medicated
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints due to arthritis simple backache strains sprains bursitis tendonitis bruises cramps

Dosage and administration

adults and children 12 years and over: apply patch to affected area as needed but not more than 4 times daily children under 12 years: ask a doctor for easy application; partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Menthol - Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints due to

  • arthritis
  • simple backache
  • strains
  • sprains
  • bursitis
  • tendonitis
  • bruises
  • cramps

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with eyes or on mucous membranes
  • do not apply to wounds or to damaged or very sensitive skin
  • do not bandage tightly or use with a heating pad

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • excessive redness or irritation is present
  • condition worsens
  • pain 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.

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 and over: apply patch to affected area as needed but not more than 4 times daily
  • children under 12 years: ask a doctor
  • for easy application; partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin.

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxypropyl cellulose, kaolin, partially neutralized polyacrylate, polyvinyl alcohol, purified water, sorbitol solution, tartaric acid

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold and Hot Medicated Patch
Cold and Hot Medicated Patch

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts
Drug Facts

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold and Hot Medicated Patch
Cold and Hot Medicated Patch

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts
Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN6
420222menthol 0.05 MG/MG Medicated PatchSCD6
420222menthol 5 % Medicated PatchSY6

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-1117-12023-02-14C16284748780-1f386c649-cd46-0266-e053-dadaa90a7c1aDrug Facts - Cold and Hot Medicated
10742-1118-12023-02-14C16284748780-1f386c649-cd46-0266-e053-dadaa90a7c1aDrug Facts - Cold and Hot Medicated
10742-1117-12023-01-30C16284748780-1f386c649-cd46-0266-e053-dadaa90a7c1aDrug Facts - Cold and Hot Medicated
10742-1118-12023-01-30C16284748780-1f386c649-cd46-0266-e053-dadaa90a7c1aDrug Facts - Cold and Hot Medicated

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-1117-1Cold and Hot Medicated5 in 1 POUCHPATCH56
10742-1117-1Cold and Hot Medicated1 in 1 CARTONPATCH16
10742-1118-1Cold and Hot Medicated5 in 1 POUCHPATCH56
10742-1118-1Cold and Hot Medicated1 in 1 CARTONPATCH16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-1117COLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]6Current NDC, Legacy NDC, 2 package rows20241215_85bf425d-59d7-4462-ba46-292145460099.zip
10742-1118COLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]6Current NDC, Legacy NDC, 2 package rows20241215_85bf425d-59d7-4462-ba46-292145460099.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A3
MENTHOLACTIVE MOIETYL7T10EIP3A3
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK313
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3113
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G3
DIHYDROXYALUMINUM AMINOACETATEINACTIVE INGREDIENTDO250MG0W63
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RT3
POLYACRYLIC ACID (250000 MW)INACTIVE INGREDIENT9G2MAD7J6W3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9903
SORBITOLINACTIVE INGREDIENT506T60A25R3
TARTARIC ACIDINACTIVE INGREDIENTW4888I119H3
WATERINACTIVE INGREDIENT059QF0KO0R3

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
10742-111710742-1117-1
10742-111810742-1118-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
CASTOR OILD5340Y2I9GIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TARTARIC ACIDW4888I119HIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
CASTOR OILD5340Y2I9GIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TARTARIC ACIDW4888I119HIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 212 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route
60 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE E)HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTCAPSULE, EXTENDED RELEASE / ORAL23 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii+route
60 equally ranked IID candidates
SORBITOLSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii+route
32 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31SOLUTION / TOPICAL11 mgExact identifier — unii+route
24 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31GEL / TOPICAL81 mgExact identifier — unii+route
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route
60 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii+route
32 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii+route
32 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311LOTION / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route
60 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HSYSTEM / TOPICAL349 mgExact identifier — unii+route
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route
60 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HSYSTEM / TOPICAL349 mgExact identifier — unii+route
4 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii+route
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii+route
60 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE E)HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTCAPSULE, EXTENDED RELEASE / ORAL23 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route
60 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii+route
60 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route
60 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLOTION / TOPICAL10.7 %w/wExact identifier — unii+route
32 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE E)HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTTABLET, FILM COATED / ORAL15 mgExact identifier — unii candidate
12 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31CREAM / TOPICAL214 mgExact identifier — unii+route
24 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii+route
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
60 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SYSTEM / TOPICAL420 mgExact identifier — unii+route
8 equally ranked IID candidates
POLYACRYLIC ACID (250000 MW)POLYACRYLIC ACID (250000 MW)9G2MAD7J6WSYSTEM / TOPICAL196 mgExact identifier — unii+route
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route
60 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+route
60 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii+route
32 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii+route
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii+route
60 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii+route
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii+route
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii+route
60 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii+route
44 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31SUSPENSION/ DROPS / TOPICAL0.4 %w/vExact identifier — unii+route
24 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii+route
8 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii+route
32 equally ranked IID candidates
SORBITOLSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii+route
32 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / TOPICAL1 %w/wExact identifier — unii+route
32 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii+route
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
60 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii+route
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii+route
32 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLOTION / TOPICAL10.7 %w/wExact identifier — unii+route
32 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31LOTION / TOPICAL0.3 %w/wExact identifier — unii+route
24 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE E)HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTCAPSULE, DELAYED RELEASE / ORAL83 mgExact identifier — unii candidate
12 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31LOTION / TOPICAL0.3 %w/wExact identifier — unii+route
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii+route
60 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii+route
32 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii+route
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii+route
32 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31LOTION / TOPICAL0.3 %w/wExact identifier — unii+route
24 equally ranked IID candidates

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 MedicatedMENTHOLThe Mentholatum Company85bf425d-59d7-4462-ba46-2921454600992024-12-13WarningsExact identifier
ndc (package): 10742-1117-1
ndc (package): 10742-1118-1
ndc (product): 10742-1118
ndc (product): 10742-1117
ndc11 (package): 10742111801
ndc11 (package): 10742111701
spl id: 292bbecc-0909-ea75-e063-6394a90a7e64
spl set id: 85bf425d-59d7-4462-ba46-292145460099

Reported adverse events (FAERS/openFDA)#

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