Active Ingredient
LIDOCAINE 4%
Jengufun Lidocaine Pain Relief Gel-patch
FDA Label NDC 69561-007
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 Kangdi Medical Devices Co., Ltd. for the product Jengufun Lidocaine Pain Relief Gel-patch (NDC 69561-007). 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 are allergic to any ingredients of this product
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
■ condition worsen
■ symptoms persist far more than 7 days
■ symptoms clear up and occur again within a few days
Ask Doctor
lf pregnant or breast-feeding
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Centerright away.
Directions
Adult 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-hour application
■ Children under 12 years of age: consult a doctor
Other Information
■ Avoid storing product in direct sunlight
■ Protect product from excessive moisture
Inactive Ingredients
Dihydroxyaluminum Aminoacetate,Edetate Disodium,Glycerin,Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral oil.Polysorbate 80, Polyacrylic Acid,Polyvinylpyrrolidone K90,Propylene Glycol, Sodium Polyacrylate,Titanium Dioxide,Water.
Questions
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