Otc - Active Ingredient
Lidocaine 4%
Lidocaine Knee Pain Relief Gel-patch
FDA Label NDC 84165-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Zhupuyou E-commerce Co., Ltd for the product Lidocaine Knee Pain Relief Gel-patch (NDC 84165-014). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Anesthetic
Indications & Usage
Temporarily relieves muscie soreness and minor jointpains in the wrist, knecs, back, neck, hips, shoulders.elboxws.
Warnings
For external use only
Otc - Do Not Use
more than 1 patch on your body at a time or with other topical anesthetics at the same time.
on wounds or damaged skin.
with a heating pad or device
with other ointments, creams, sprays, or liniments
if you are allergic to any ingredients of this product
Otc - When Using
use only as directed
s avoid contact with the eyes, mucous membranes, orrashes
do not bandage tightly
dispose of used patch in manner that always keeps product away from children and pets. Used patche still contain the drug product that can produce serious adverse eflects if a child or pet chews or ingests this patch
Otc - Stop Use
localized skin reactions occur, such as rash, itchingredness, iritation, pain, swelng and blistering
condition worsens
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
lf swallowved accidentally , get medical help orcontact with Poison Control Center immediately
Dosage & Administration
Adults and Children above 12 years old:
Clean and dry the affected area.
Tear off the protective film and apply the exposed part of the patch to the affected area.
Carefully remwe remaining film while pressing the patch firmly on the skin.
Apply 1 patch at a time to afiected area, not morethan 3 to 4 times dally.
Remove patch from the skin after at most 8-hour application
Children under age of 12:Consuit a doctor
Inactive Ingredient
Dihydroxyaluminum Aminoacetate Anhydrous
Edetate Disodium
Glycerin
Kaolin
Methylparaben
Polyacrylic Acid
Polysorbate 80
PolyvinylPyrrolidone K90
Propylene Glycol
Propylparaben
Sodium Polyacrylate
Tartaric Acid
Titanium Dioxide
Water
Package Label.Principal Display Panel
Label1 (Label1)
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