Toplast Cool and Hot Menthol 4percent plus Capsaicin 0.025percent

Manufacturer
Icure Pharmaceutical Inc, Wanju Factory
Effective date
2020-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:55

Label at a glance#

ProductToplast Cool and Hot Menthol 4percent plus Capsaicin 0.025percent
Active ingredientMenthol, Capsaicin
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) ■ Apply to affected area not more than 3 to 4 times daily ■ Suggested duration of use for patch is upto 8 hours Children under 12 years of age : Consult a physician

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%
Capsicum extract 0.025% as Capsaicin

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

WARNINGS

WARNINGS SECTION

For external use only
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Do not use
■ On wounds or damaged skin
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Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients
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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 ■ Discontinue use at least 1 hour before a bath or shower ■ Do not use immediately after a bath or shower
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Stop use and ask a doctor if
■ Condition worsens ■ Rash, itching or excessive skin irritation develops ■ Symptoms persist for more than 7 days or reoccur within a few days interval
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If pregnant or breast-feeding, ask a health professional before use

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) ■ Apply to affected area not more than 3 to 4 times daily ■ Suggested duration of use for patch is upto 8 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
2383952capsaicin 0.025 % / menthol 4 % Medicated PatchPSN1
2383952capsaicin 0.00025 MG/MG / menthol 0.04 MG/MG Medicated PatchSCD1
2383952capsaicin 0.025 % / menthol 4 % Medicated PatchSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73279-0017-22022-01-28C16284748780-1d6a99b39-de46-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73279-0017-1Toplast Cool and Hot Menthol 4percent plus Capsaicin 0.025percent5 in 1 POUCHPATCH51
73279-0017-2Toplast Cool and Hot Menthol 4percent plus Capsaicin 0.025percent2 in 1 CARTONPATCH21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73279-0017TOPLAST COOL AND HOT MENTHOL 4PERCENT PLUS CAPSAICIN 0.025PERCENT (MENTHOL, CAPSAICIN) PATCH [ICURE PHARMACEUTICAL INC, WANJU FACTORY]1Legacy NDC, 2 package rows20200728_f2aaf8a3-30c0-4c3e-a5a3-71b1573fe119.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73279-001773279-0017-1, 73279-0017-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
68382315-b18b-42ba-953c-c03a3abb7037f2aaf8a3-30c0-4c3e-a5a3-71b1573fe1192020-07-28WarningsExact identifier
spl id: 68382315-b18b-42ba-953c-c03a3abb7037
spl set id: f2aaf8a3-30c0-4c3e-a5a3-71b1573fe119

Reported adverse events (FAERS/openFDA)#

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