Otc - Active Ingredient
LIDOCAINE 4%
MENTHOL 1%
Plantar Fasciitis Pain Relief Gel-patch
FDA Label NDC 84165-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Zhupuyou E-commerce Co., Ltd for the product Plantar Fasciitis Pain Relief Gel-patch (NDC 84165-007). 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 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 jointpains 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 withother 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
avoid contact with the eyes, mucous membranes, or rashes
do not bandage tightly
dispose of used patch in manner that always keepsproduct away from children and pets. Used patchesstill contain the drug product that can produce seriousadverse 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
econdition 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 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 exposedpart of the patch to the affected area.
Carefully remove remaining film while pressingthe patch fimmly on the skin.
Apply 1 patch at a time to affected area, not morethan 3 to 4 times daily.
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
Package Label.Principal Display Panel
Label1 (Label1)
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