Cool n Heat Patch for Back

Manufacturer: Walgreen Co.
Effective date: 2013-10-15
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:37:12

Label at a glance#

ProductCool n Heat Patch for Back Extra Strength

Active ingredientMenthol

Label structure12 sections

Storage and handling

Other information store at room temperature

Contacts and useful links#

PhoneLabel contact1-800-925-4733

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Menthol 5%

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves minor pain associated with:

arthritis
simple backache
bursitis
tendonitis
muscle strains
muscle sprains
bruises
cramps

WARNINGS SECTION

Warnings

For external use only
If pregnant or breast-feeding, ask a health professional before use.

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

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 right away.

DOSAGE & ADMINISTRATION SECTION

Directions

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
apply one patch to affected area
repeat as necessary, but no more than 4 times daily

Children under 12 years of age consult a doctor

STORAGE AND HANDLING SECTION

Other information

store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe barbadensis leaf juice, alumina magnesium metasilicate, aluminum hydroxide, BHT, castor oil, disodium EDTA, gelatin, glycerin, isopropyl myristate, kaolin, methylparaben, PEG-4 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

OTC - QUESTIONS SECTION

Questions or comments?

1-800-WALGREENS (1-800-925-4733)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of box label

Image of pouch label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
420222	menthol 5 % Medicated Patch	PSN	3
420222	menthol 0.05 MG/MG Medicated Patch	SCD	3
420222	menthol 5 % Medicated Patch	SY	3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
0363-0152-01	2020-01-31	C162847	48780-1	9d75b9d0-afe4-f424-e053-dadaa90a57ce	Menthol 5% (Topical Analgesic)
0363-0152-02	2020-01-31	C162847	48780-1	9d75b9d0-afe4-f424-e053-dadaa90a57ce	Menthol 5% (Topical Analgesic)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0152-01	Cool n Heat Patch for BackExtra Strength	1 g in 1 PATCH	PATCH	1	3
0363-0152-01	Cool n Heat Patch for BackExtra Strength	5 in 1 BOX	PATCH	5	3
0363-0152-02	Cool n Heat Patch for BackExtra Strength	3 in 1 BOX	PATCH	3	3
0363-0152-02	Cool n Heat Patch for BackExtra Strength	1 g in 1 PATCH	PATCH	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0152	COOL N HEAT PATCH FOR BACK EXTRA STRENGTH (MENTHOL) PATCH [WALGREEN CO.]	3	Legacy NDC, 4 package rows	20131015_1f86a35b-a7df-4692-8c6b-cca8d7fad83e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	3
Menthol	ACTIVE MOIETY	L7T10EIP3A	3
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	3
Alpha-Tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	3
Aluminum Hydroxide	INACTIVE INGREDIENT	5QB0T2IUN0	3
Butylated Hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	3
Castor Oil	INACTIVE INGREDIENT	D5340Y2I9G	3
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	3
Gelatin	INACTIVE INGREDIENT	2G86QN327L	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	3
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	3
Kaolin	INACTIVE INGREDIENT	24H4NWX5CO	3
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	3
PEG-4 Stearate	INACTIVE INGREDIENT	J33E8608YN	3
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	3
Polyvinyl Alcohol	INACTIVE INGREDIENT	532B59J990	3
Silodrate	INACTIVE INGREDIENT	9T3UU8T0QK	3
Tartaric Acid	INACTIVE INGREDIENT	W4888I119H	3
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	3
Water	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

Cool n Heat Patch for Back Extra Strength
Menthol
Aloe Vera Leaf
Aluminum Hydroxide
Edetate Disodium
Gelatin
Kaolin
Methylparaben
Glycerin
Titanium Dioxide
Isopropyl Myristate
Water
PEG-4 Stearate
Polyvinyl Alcohol
Polysorbate 80
Alpha-Tocopherol Acetate
Silodrate
Castor Oil
Tartaric Acid
Butylated Hydroxytoluene

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-0152	0363-0152-01, 0363-0152-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Menthol	L7T10EIP3A	ACTIB
Aloe Vera Leaf	ZY81Z83H0X	IACT
Aluminum Hydroxide	5QB0T2IUN0	IACT
Edetate Disodium	7FLD91C86K	IACT
Gelatin	2G86QN327L	IACT
Kaolin	24H4NWX5CO	IACT
Methylparaben	A2I8C7HI9T	IACT
Glycerin	PDC6A3C0OX	IACT
Titanium Dioxide	15FIX9V2JP	IACT
Isopropyl Myristate	0RE8K4LNJS	IACT
Water	059QF0KO0R	IACT
PEG-4 Stearate	J33E8608YN	IACT
Polyvinyl Alcohol	532B59J990	IACT
Polysorbate 80	6OZP39ZG8H	IACT
Alpha-Tocopherol Acetate	9E8X80D2L0	IACT
Silodrate	9T3UU8T0QK	IACT
Castor Oil	D5340Y2I9G	IACT
Tartaric Acid	W4888I119H	IACT
Butylated Hydroxytoluene	1P9D0Z171K	IACT

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 9 · 522 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TOPICAL		29 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / TOPICAL		65000 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 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
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 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	CAPSULE / ORAL	418.37 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Tartaric Acid	TARTARIC ACID	W4888I119H	SOLUTION / ORAL		270 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Tartaric Acid	TARTARIC ACID	W4888I119H	TABLET / ORAL		63 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 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	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	WAFER / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 32 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
Methylparaben	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Tartaric Acid	TARTARIC ACID	W4888I119H	INJECTION, SOLUTION / INTRAMUSCULAR		18 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	FILM, SOLUBLE / ORAL	0.06 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Tartaric Acid	TARTARIC ACID	W4888I119H	TABLET, ORALLY DISINTEGRATING / ORAL		45 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	ENEMA / RECTAL	0.01 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	CAPSULE, COATED / ORAL		288 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Kaolin	KAOLIN	24H4NWX5CO	SYRUP / ORAL	10 mg/1ml		Exact identifier — unii candidate 13 equally ranked IID candidates
Polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Kaolin	KAOLIN	24H4NWX5CO	CAPSULE, DELAYED RELEASE PELLETS / ORAL		234 mg	Exact identifier — unii candidate 13 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
a9a1b401-911e-4504-a898-657326fa2c20			1f86a35b-a7df-4692-8c6b-cca8d7fad83e	2013-10-15	Warnings	Exact identifier spl id: a9a1b401-911e-4504-a898-657326fa2c20 spl set id: 1f86a35b-a7df-4692-8c6b-cca8d7fad83e

Reported adverse events (FAERS/openFDA)#

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