Extra Large Cool and Heat Patch

Manufacturer
Walgreen Company | Foshan Aqua Gel Biotech Co.,Ltd.
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:50

Label at a glance#

ProductExtra Large Cool and Heat Patch
Active ingredientMENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient ...............................................................................................Purpose
Menthol 5%...............................................................................................Topical Analgesic

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

CMC, Dihydroxy aluminum Aminoacetate, Glycerin, Kaolin, Mineral Oil, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.

WARNINGS

WARNINGS SECTION

For External Use Only.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years: Carefully remove backing from patch. Apply sticky side of patch to affected area.

Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. Reseal pouch after opening.

Children 12 years or younger: Consult a physician.

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

When using this product

OTC - WHEN USING SECTION

When using this product ■ Use only as directed ■ Rare cases of serious burns have been reported with products of this type ■ Don’t bandage tightly or use with heating pad ■ Avoid contact with eyes and mucous membranes ■ Don’t apply to wounds or damaged skin ■ Do not use at the same time as other topical analgesics.

Stop use and ask a doctor

OTC - STOP USE SECTION

■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or clear up and occur again within a few days ■ You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN4
420222menthol 0.05 MG/MG Medicated PatchSCD4
420222menthol 5 % Medicated PatchSY4

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
0363-9905-03Extra Large Cool and Heat Patch3 in 1 BOXPATCH34
0363-9905-03Extra Large Cool and Heat Patch9 g in 1 POUCHPATCH94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9905EXTRA LARGE COOL AND HEAT PATCH (MENTHOL) PATCH [WALGREEN COMPANY]4Current NDC, Legacy NDC, 2 package rows20241220_9fd83f89-0dd0-4f22-9c8e-a353864ea43b.zip

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
0363-99050363-9905-03

Ingredients#

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

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

Source Document#

Source XML · Source PDF

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
Extra Large Cool and Heat PatchMENTHOLWalgreen Company9fd83f89-0dd0-4f22-9c8e-a353864ea43b2024-12-18WarningsExact identifier
ndc (package): 0363-9905-03
ndc (product): 0363-9905
ndc11 (package): 00363990503
spl id: 298f9da2-8c9d-5ff3-e063-6394a90a71bf
spl set id: 9fd83f89-0dd0-4f22-9c8e-a353864ea43b

Reported adverse events (FAERS/openFDA)#

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