FDA.reportPublic FDA data

Walgreens Cool N Heat Back Patch

Manufacturer
Walgreen Co.
Effective date
2026-03-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:51:48

Label at a glance#

ProductWalgreens Cool N Heat Back Patch
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

Adults and children 12 years of age and older: remove backing from patch by firmly grasping both ends and gently pulling until backing separates in the middle place exposed portion of patch backing to affected area and press to skin carefully remove the remaining film while pressing the patch firmly on the skin use on affected area not more than 3 to 4 times daily. use one patch per application discard after use r...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on wounds or on irritated 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
  • do not bandage tightly
  • avoid contact with the yes or mucous membranes
  • do not expose the area to local heat or direct sunlight
  • a transient burning sensation may occur upon application but generally disappears in several days
  • avoid applying into skin folds

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • redness is present or excessive irritation occurs
  • you experience severe burning, pain, swelling, or blistering where the product is applied

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 of age and older:
  • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in the middle
  • place exposed portion of patch backing to affected area and press to skin
  • carefully remove the remaining film while pressing the patch firmly on the skin
  • use on affected area not more than 3 to 4 times daily.
  • use one patch per application
  • discard after use
  • reseal pouch after opening
  • wash hands after applying and removing patch
  • Children under 12 years of age: consult a physician

Other information

OTHER SAFETY INFORMATION

  • store at 20-25°C (68-77°F)
  • store in a cool dry place, away from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cellulose Gum, Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Principal Display Panel - 7.87 IN x 3.93 IN Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

Compare to the active ingredient in Original Strength Icy Hot ® Medicated Patch

Cool n' Heat

Patch

Menthol 5% / Topical Analgesic

For Back

Medicated

  • Targeted pain relief
  • For the temporary relief of minor aches & pains
  • Flexible, single-use application

5 PATCHES

7.87 IN x 3.93 IN (20 cm x 10 cm) EACH

Packaged in a resealable pouch

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN3
420222menthol 0.05 MG/MG Medicated PatchSCD3
420222menthol 5 % Medicated PatchSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130311917080932GTIN-13: 0311917080932
EAN-13: 0311917080932
GTIN-12: 311917080932
UPC-A: 311917080932
GTIN storage (14 digits): 00311917080932		766657_CoolnHeatPatch_BOX-1.jpg

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
0363-6657-05Walgreens Cool N Heat Back Patch11 g in 1 PATCHPATCH113
0363-6657-05Walgreens Cool N Heat Back Patch5 in 1 BOXPATCH53

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
0363-66570363-6657-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
PETROLATUM4T6H12BN9UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
TARTARIC ACIDW4888I119HIACT
KAOLIN24H4NWX5COIACT
POVIDONEFZ989GH94EIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
CELLULOSE GUMK679OBS311IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-02-10monthly-update2026-06-03 17:56:25

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
Walgreens Cool N Heat Back PatchMENTHOLWalgreen Co.41e81110-4b79-1fa6-e063-6394a90ae90c2026-03-27WarningsExact identifier
ndc (package): 0363-6657-05
ndc (product): 0363-6657
ndc11 (package): 00363665705
spl id: 4e0691f0-fc4f-3598-e063-6394a90a2217
spl set id: 41e81110-4b79-1fa6-e063-6394a90ae90c

Reported adverse events (FAERS/openFDA)#

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