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AUVON LIDOCAINE MENTHOL Pain Relief Patch
Auvon Lidocaine Menthol Pain Relief Patch
FDA Label NDC 83391-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Yuwen E-commerce Co., Ltd. for the product Auvon Lidocaine Menthol Pain Relief Patch (NDC 83391-008). 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
for the temporary pain relief
Warnings
For external use only
Otc - Do Not Use
If you are allergic to the listed ingredients
If you are pregnent or breast feeding
If you are under 12 years of age
On wounds, cuts, damaged/broken/irritated skin
On eyes or mucous membranes
With heating pads/devices or wrap with a bandage
With other topical analgesics
If the package arrives damaged or opened.
Otc - When Using
■ Read and follow all directions and warnings on this label
■ avoid contact with the eyes and mucous membranes
■ rare cases of serious burns have been reported with products of this type
■ a transient burning sensation may occur upon application but generally disappears in several days
■ 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
You are experiencing pain, swelling or blistering
Redness is persent or irritation develops
Symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Children under 12years of age: do not use, consult a doctor.
Dosage & Administration
■ Clean and dry the patch application area (no wound or hair), pull to separate the film, peel off one side of the film, apply the exposed patch to the skin, peel off the ■ Do not repeatedly use or repeatedly reapply the patch as far as possible
■ Cut first if if used on joints
■ Use in te affected area no more than 4 times daily
■ Wash hands with cool water after use
Storage And Handling
Avoid storing patches in direct sunlight
Protect patches from excessive moisture.
Store it at room temperature 20-25°c
Inactive Ingredient
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
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