Active Ingredient
Lidocaine 4%
Thermapatch (tm) Lidocaine Pain Relief Patch
FDA Label NDC 83559-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henan Enokon Medical Instrument Co., Ltd. for the product Thermapatch (tm) Lidocaine Pain Relief Patch (NDC 83559-006). 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 ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Use
For temporary relief of pain
Warnings
For external use only
Do Not Use
More than 1 patch at a time
On wounds or damaged skin
With a heating pad
If you have ever had an allergic reaction to this product or any of its ingredients
When Using
Use only as directed
Avoid contact with the eyes, mucous membranes or rashes
Do not bandage tightly
Stop Use
Localized skin reactions occur, such as rash, itching, redness, irritation, pain swelling, and blistering
Conditions worsen
Symptoms persist for more than 7 days
Symptoms clear up and occur again within a few days
Ask Doctor
If pregnant or breast-feeding, ask a health professional before use
Keep Oot Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and over:
Clean and dry affected area
Remove film from patch and apply to the skin
Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
Remove patch from the skin after at most 8 hours of application
Children under 12 years of age: consult a doctor
Other Information
Avoid storing product in direct sunlight
Protect product from excessive moisture
Store at 20-25°C (68-77°F)
Inactive Ingredients
Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Kaolin, Phenoxyethanol, Polyvinylpyrrolidone, Propylene Glycol,
Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Water
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