Indications and uses
For temporary relief of minor pain
For temporary relief of minor pain
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
Lidocaine 4%
Menthol 1%
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
Topical Anesthetic
Topical Analgesic
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
If swallowed, get medical help or contact a Poison Control Center right away
For temporary relief of minor pain
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
■ 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
■ Visit us at : icure.co.kr/en ■ Contact us : icurepharm@icure.co.kr
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73279-0004-2 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-9fbf-d8a0-e053-dadaa90a6e4e | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73279-0004-1 | Toplast Pain Relief Lidocaine 4percent plus Menthol 1percent | 1 in 1 POUCH | PATCH | 1 | 3 | |
| 73279-0004-2 | Toplast Pain Relief Lidocaine 4percent plus Menthol 1percent | 5 in 1 CARTON | PATCH | 5 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 73279-0004 | TOPLAST PAIN RELIEF LIDOCAINE 4PERCENT PLUS MENTHOL 1PERCENT (LIDOCAINE, MENTHOL) PATCH [ICURE PHARMACEUTICAL INC, WANJU FACTORY] | 3 | Legacy NDC, 2 package rows | 20210424_d5e31458-1d86-4064-bdbd-8a2782c621aa.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 73279-0004 | 73279-0004-1, 73279-0004-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Lidocaine | 98PI200987 | ACTIB |
| Menthol | L7T10EIP3A | ACTIB |
| Glycerin | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Urea | 8W8T17847W | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED | K679OBS311 | IACT |
| Gelatin | 2G86QN327L | IACT |
| Kaolin | 24H4NWX5CO | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| Tartaric Acid | W4888I119H | IACT |
| Dihydroxyaluminum Aminoacetate | DO250MG0W6 | IACT |
| Methylparaben | A2I8C7HI9T | IACT |
| Polysorbate 80 | 6OZP39ZG8H | IACT |
| SORBITAN MONOOLEATE | 06XEA2VD56 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| Propylparaben | Z8IX2SC1OH | IACT |
| Water | 059QF0KO0R | IACT |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| bebd9d71-2689-4dfb-a276-e6f5b8153d80 | d5e31458-1d86-4064-bdbd-8a2782c621aa | 2021-04-23 | Warnings | bebd9d71-2689-4dfb-a276-e6f5b8153d80 d5e31458-1d86-4064-bdbd-8a2782c621aa |
Adverse event summaries are temporarily unavailable. Other product information remains available.