Toplast Pain Relief Lidocaine 4percent

Manufacturer
Icure Pharmaceutical Inc, Wanju Factory
Effective date
2020-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:29

Label at a glance#

ProductToplast Pain Relief Lidocaine 4percent
Active ingredientLidocaine
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 for up to 12 hours Children under 12 years of age : Consult a physician

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PURPOSE

OTC - PURPOSE SECTION

Topical Anesthetic

WARNINGS

WARNINGS SECTION

For external use only
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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
--------------------------------------------------------------------------------------------------------
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 ■ 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
--------------------------------------------------------------------------------------------------------
Stop use and ask a doctor if
■ 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 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 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 for up to 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
1737778lidocaine 4 % Medicated PatchPSN1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1
1737778lidocaine 4 % Medicated PatchSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73279-0005-22022-01-28C16284748780-1d6a99b39-775b-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73279-0005-1Toplast Pain Relief Lidocaine 4percent1 in 1 POUCHPATCH11
73279-0005-2Toplast Pain Relief Lidocaine 4percent5 in 1 CARTONPATCH51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73279-0005TOPLAST PAIN RELIEF LIDOCAINE 4PERCENT (LIDOCAINE) PATCH [ICURE PHARMACEUTICAL INC, WANJU FACTORY]1Legacy NDC, 2 package rows20200716_21208a66-b293-4429-8c87-4bca2290df4f.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73279-000573279-0005-1, 73279-0005-2

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
ebff09a4-0f67-4de0-8729-99a9321b683421208a66-b293-4429-8c87-4bca2290df4f2020-07-16WarningsExact identifier
spl id: ebff09a4-0f67-4de0-8729-99a9321b6834
spl set id: 21208a66-b293-4429-8c87-4bca2290df4f

Reported adverse events (FAERS/openFDA)#

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