Toplast Pain Relief Lidocaine 4percent plus Menthol 1percent

Manufacturer
Icure Pharmaceutical Inc, Wanju Factory
Effective date
2021-04-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:39:55

Label at a glance#

ProductToplast Pain Relief Lidocaine 4percent plus Menthol 1percent
Active ingredientLidocaine, Menthol
Label structure10 sections

Indications and uses

For temporary relief of minor pain

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

Lidocaine 4%
Menthol 1%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Glycerin, D-Sorbitol Solution, Propylene Glycol, Sodium Polyacrylate, Polyacrylic Acid, Urea, Carboxymethylcellulose Sodium, Gelatin, Kaolin, Titanium Oxide, Tartaric Acid, Dihydroxyaluminum Aminoacetate, Methylparaben, Polysorbate 80, Sorbitan Oleate, Disodium Edetate Hydrate, Propylparaben, Water

PURPOSE

OTC - PURPOSE SECTION

Topical Anesthetic
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
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Do not use
■ More than 1 patch on your body at a time ■ On the cut, irritated, swollen or puncture wounds ■ For more than one week without consulting a doctor
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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 ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ Do not use at the same time as other topical analgesics ■ Make sure to dispose the used patch away from children and pets, as used ones still contain the drug that can cause serious adverse effects on them if they chew or ingest the patch
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Stop use and ask a doctor if
■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or recur ■ Skin swells or blisters where the product was applied
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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 pain

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
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN3
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD3
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
73279-0004-22022-07-29C16284748780-1e4f33bdf-9fbf-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73279-0004-1Toplast Pain Relief Lidocaine 4percent plus Menthol 1percent1 in 1 POUCHPATCH13
73279-0004-2Toplast Pain Relief Lidocaine 4percent plus Menthol 1percent5 in 1 CARTONPATCH53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73279-0004TOPLAST PAIN RELIEF LIDOCAINE 4PERCENT PLUS MENTHOL 1PERCENT (LIDOCAINE, MENTHOL) PATCH [ICURE PHARMACEUTICAL INC, WANJU FACTORY]3Legacy NDC, 2 package rows20210424_d5e31458-1d86-4064-bdbd-8a2782c621aa.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73279-000473279-0004-1, 73279-0004-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
bebd9d71-2689-4dfb-a276-e6f5b8153d80d5e31458-1d86-4064-bdbd-8a2782c621aa2021-04-23WarningsExact identifier
spl id: bebd9d71-2689-4dfb-a276-e6f5b8153d80
spl set id: d5e31458-1d86-4064-bdbd-8a2782c621aa

Reported adverse events (FAERS/openFDA)#

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