Toplast Cool Menthol 5percent

Manufacturer
Icure Pharmaceutical Inc, Wanju Factory
Effective date
2021-04-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:39:56

Label at a glance#

ProductToplast Cool Menthol 5percent
Active ingredientMenthol
Label structure10 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with : ■ Simple backache ■ Arthritis ■ Strains ■ Bruises ■ Sprains

Dosage and administration

Adult and children 12 years of age and over : ■ Clean and dry affected area ■ Peel film from patch and apply to the skin (see illustration) ■ Use 1 patch at a time and do not use for more than 12 hours Children under 12 years of age : consult a physician

Label contents#

Full prescribing information#

Active Ingredients (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Glycerin, Propylene Glycol, Sodium Polyacrylate, Gelatin, Polyvinylpyrrolidone, Carboxymethylcellulose Sodium, Polyvinyl Alcohol, Kaolin, Titanium Oxide, Tartaric Acid, Polysorbate 80, Sorbitan Monooleate, Disodium Edetate Hydrate, Dihydroxyaluminum Aminoacetate, Water

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

WARNINGS

WARNINGS SECTION

For external use only
Safety Warning : Prior to using the product, conduct a skin patch test on your forearm to assess sensitivity and/or allergic reactions
--------------------------------------------------------------------------------------------------------
Do not use
■ On wounds or damaged skin
--------------------------------------------------------------------------------------------------------
Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients
--------------------------------------------------------------------------------------------------------
When using this product
■ Use only as directed ■ Read and follow all directions and warnings on this label ■ Do not allow contact with the eyes and mucous membranes or rashes ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use
--------------------------------------------------------------------------------------------------------
Stop use and ask a doctor if
■ Condition worsens ■ Rash, itching or excessive skin irritation develops ■ Symptoms persist for more than 7 days or recur ■ Skin swells or blisters where the product was applied
--------------------------------------------------------------------------------------------------------
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with : ■ Simple backache ■ Arthritis ■ Strains ■ Bruises ■ Sprains

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 12 years of age and over :
■ Clean and dry affected area ■ Peel film from patch and apply to the skin (see illustration) ■ Use 1 patch at a time and do not use for more than 12 hours
Children under 12 years of age : consult a physician

Other Information

OTHER SAFETY INFORMATION

■ Store at room temperature 68° to 77°F (20° to 25°C) ■ Store in a clean, dry place out of direct sunlight ■ Protect from excessive moisture

Questions or Comments

OTC - QUESTIONS SECTION

■ Visit us at : icure.co.kr/en ■ Contact us : icurepharm@icure.co.kr

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN2
420222menthol 0.05 MG/MG Medicated PatchSCD2
420222menthol 5 % Medicated PatchSY2

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
73279-0015-22022-07-29C16284748780-1e4f33bdf-aa2e-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73279-0015-1Toplast Cool Menthol 5percent5 in 1 POUCHPATCH52
73279-0015-2Toplast Cool Menthol 5percent2 in 1 CARTONPATCH22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73279-0015TOPLAST COOL MENTHOL 5PERCENT (MENTHOL) PATCH [ICURE PHARMACEUTICAL INC, WANJU FACTORY]2Legacy NDC, 2 package rows20210424_fb468409-4202-4de6-b932-1fbb6c3b8256.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73279-001573279-0015-1, 73279-0015-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

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
14abc685-7328-4b4c-b1d0-0a6126ed70d5fb468409-4202-4de6-b932-1fbb6c3b82562021-04-23WarningsExact identifier
spl id: 14abc685-7328-4b4c-b1d0-0a6126ed70d5
spl set id: fb468409-4202-4de6-b932-1fbb6c3b8256

Reported adverse events (FAERS/openFDA)#

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