Active Ingredient
Lidocaine 4%
Inknows Lidocaine Pain Relief Gel-patch
FDA Label NDC 83559-022
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 Inknows Lidocaine Pain Relief Gel-patch (NDC 83559-022). 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, uses, 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
Uses
For temporary relief of pain
Warnings
For external use only
Do Not Use
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
When using this product
*use only as directed
*avoid contact with the eyes, mucous membranes or rashes
*do not bandage tightly
Stop Use
Stop use and ask a doctor if
*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
Ask Doctor
*If pregnant or breast-feeding, ask a health professional before use.
*Children under 12 years of age: Consult a doctor
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions
Adults and children 12 years of age and over
*clean and dry affected area
*remove film from patch and apply to the skin (see illustration)
*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
Other Information
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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