Other
PAIN RELIEF Gel-Patch
Pain Relief Gel-patch
FDA Label NDC 84165-104
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 Pain Relief Gel-patch (NDC 84165-104). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Lidocaine 4%
Menthol 1%
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
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
avoid contact with the eyes, mucous membranes, or rashes
do not bandage tightly
Otc - Stop Use
skin reactions such as redness, swelling, blistering or other discomfort occur
symptoms persist for more than 7 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 ofthe patch to the the affected area.
Carefully remove remaining film while pressing the patchfirmly on the skin.
Remove patch from the skin after at most 8-hourapplication.
Children under age of 12: Consult a doctor
Inactive Ingredient
Dihydroxyaluminum Aminoacetate
Edetate Disodium
Glycerin
Hydroxyacetophenone
Kaolin
Mineral Oil
Polyacrylic Acid
Polysorbate 80
PolyvinylPyrrolidone
Propylene Glycol
Sodium Polyacrylate
Tartaric Acid
Titanium Dioxide
Water
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