Otc - Active Ingredient
Lidocaine 4%
Sumifun Lidocaine Pain Relief Gel-patch
FDA Label NDC 84165-016
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 Sumifun Lidocaine Pain Relief Gel-patch (NDC 84165-016). 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 muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders,elbows.
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 devicemwith other ointments, creams, sprays, or liniments
if you are allergic to any ingredients of this product
Otc - When Using
use only as directed
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 patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Otc - Stop Use
localized skin reactions occur, such as rash, itching,redness, irritation, pain, swelling 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 swallowed accidentally , get medical help or contact 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 remove remaining film while pressing the patch firmly on 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-hour application
Children under age of 12:Consult 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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