cold hot patch

Manufacturer: Simple Diagnostics, Inc.
Effective date: 2015-02-23
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:41:46

Label at a glance#

Productcold hot patch

Active ingredientMENTHOL

Label structure7 sections

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: grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates. Remove protective film while applying pad directly to site of pain.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.00%.

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
.bursitis .tendonitis . Bruises . Cramps

Warnning

WARNINGS SECTION

For external use only.
When using this product.use only as directed . avoid contact with eyes and mucous membranes. do not apply to wounds or damaged skin.do not bandage tightly or use a heating pad
Stop use and ask doctor if
.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, ask a health professional before use, keep out of reach of childeren.If swallowed, get medical help or contact a poison control center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childeren.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: grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates.
Remove protective film while applying pad directly to site of pain.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylic Acid,Aluminum Hydroxide,Carmellose Sodium,2 Ethylhexyl Acrylate,Glycerin,Isopropyl Myristate,Methyl Acrylate,Nonoxynol 30,
Polyacrylate,Polyacrylic Acid,Polysorbate 80,Sorbitan Sesquioleate,Starch,Talc,Tartaric Acid,Titanium Dioxide,Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
420222	menthol 5 % Medicated Patch	PSN	1
420222	menthol 0.05 MG/MG Medicated Patch	SCD	1
420222	menthol 5 % Medicated Patch	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62379-001-35	2020-01-31	C162847	48780-1	9d75b9d0-dcf3-f424-e053-dadaa90a57ce	cold & hot patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62379-001-25	cold hot patch	.408 g in 1 PATCH	PATCH	.408	1
62379-001-35	cold hot patch	12 in 1 PACKAGE	PATCH	12	1
62379-001-35	cold hot patch	4 in 1 CARTON	PATCH	4	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62379-001	COLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]	1	Legacy NDC, 3 package rows	20150224_0fc7f516-d1ed-258c-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	1
2-ETHYLHEXYL ACRYLATE	INACTIVE INGREDIENT	HR49R9S6XG	1
ACRYLIC ACID	INACTIVE INGREDIENT	J94PBK7X8S	1
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	1
METHYL ACRYLATE	INACTIVE INGREDIENT	WC487PR91H	1
NONOXYNOL-30	INACTIVE INGREDIENT	JJX07DG188	1
POLYACRYLIC ACID (8000 MW)	INACTIVE INGREDIENT	73861X4K5F	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
SODIUM POLYACRYLATE (8000 MW)	INACTIVE INGREDIENT	285CYO341L	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	1
STARCH, POTATO	INACTIVE INGREDIENT	8I089SAH3T	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

cold hot patch
Menthol
ACRYLIC ACID
ALUMINUM HYDROXIDE
CROSCARMELLOSE SODIUM
2-ETHYLHEXYL ACRYLATE
GLYCERIN
ISOPROPYL MYRISTATE
METHYL ACRYLATE
NONOXYNOL-30
SODIUM POLYACRYLATE (8000 MW)
POLYACRYLIC ACID (8000 MW)
POLYSORBATE 80
SORBITAN SESQUIOLEATE
STARCH, POTATO
TALC
TARTARIC ACID
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62379-001	62379-001-25, 62379-001-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACRYLIC ACID	J94PBK7X8S	IACT
ALUMINUM HYDROXIDE	5QB0T2IUN0	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
2-ETHYLHEXYL ACRYLATE	HR49R9S6XG	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
METHYL ACRYLATE	WC487PR91H	IACT
NONOXYNOL-30	JJX07DG188	IACT
SODIUM POLYACRYLATE (8000 MW)	285CYO341L	IACT
POLYACRYLIC ACID (8000 MW)	73861X4K5F	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SORBITAN SESQUIOLEATE	0W8RRI5W5A	IACT
STARCH, POTATO	8I089SAH3T	IACT
TALC	7SEV7J4R1U	IACT
TARTARIC ACID	W4888I119H	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT
MENTHOL	L7T10EIP3A	ACTIB

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 6 · 301 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER / TOPICAL		9235 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL / TOPICAL	9.3 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii candidate 78 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GUM, CHEWING / BUCCAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	INJECTION / INTRAMUSCULAR		11 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / TOPICAL	0.98 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
SORBITAN SESQUIOLEATE	SORBITAN SESQUIOLEATE	0W8RRI5W5A	OINTMENT / RECTAL		15 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	INJECTION, SOLUTION / INTRAMUSCULAR		18 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
ALUMINUM HYDROXIDE	ALUMINUM HYDROXIDE	5QB0T2IUN0	TABLET / ORAL	50 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, DELAYED RELEASE / ORAL		525 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE / ORAL		257 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / AURICULAR (OTIC)	0.2 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / TOPICAL		213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, POTATO	STARCH, POTATO	8I089SAH3T	TABLET / ORAL		458 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM / TRANSDERMAL	58.08 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, LIQUID FILLED / ORAL		24 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVENOUS	0.5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / RECTAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRASYNOVIAL	0.2 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, DELAYED RELEASE / ORAL		280 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TOPICAL		7 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	EMULSION / TOPICAL		34050 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SUSPENSION / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM, EXTENDED RELEASE / TRANSDERMAL	20.4 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		11 mg	Exact identifier — unii candidate 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0fc7f516-d1ee-258c-e054-00144ff8d46c			0fc7f516-d1ed-258c-e054-00144ff8d46c	2015-02-23	Warnings	Exact identifier spl id: 0fc7f516-d1ee-258c-e054-00144ff8d46c spl set id: 0fc7f516-d1ed-258c-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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