Toplast Pain Relief Lidocaine 4percent Plus Menthol 1percent
FDA Label NDC 73279-0004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Icure Pharmaceutical Inc, Wanju Factory for the product Toplast Pain Relief Lidocaine 4percent Plus Menthol 1percent (NDC 73279-0004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, inactive ingredients, purpose, warnings, keep out of reach of children and pets, uses, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine 4%
Menthol 1%

Inactive Ingredients

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

Topical Anesthetic
Topical Analgesic

Warnings

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
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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 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
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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

Uses

For temporary relief of minor pain

Directions

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

■ 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

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