Auvon Lidocaine Menthol Pain Relief
FDA Label NDC 83391-001

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 (NDC 83391-001). 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 active ingredients, purposes, use, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children and pets., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine 4%

Menthol 1%

Purposes

Topical anesthetic

Topical analgesic

Use

for the temporary pain relief

Warnings

For external use only

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.

When Using This Product

■ Use only as directed

■ 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.

Stop Use And Ask A Doctor If

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

Keep Out Of Reach Of Children And Pets.

If ingested, get medical help or contact a Poison Control Center

right away.

Directions

■ 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 other side of the film, and press the patch firmly to the skin.

■ 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

  • Avoid storing patches in direct sunlight
  • Protect patches from excessive moisture

Inactive Ingredients

Glycerin, sodium polyacrylate, dihydroxyaluminum aminoacetate,  methylparaben, propylparaben, polyacrylic acid, Kaolin, polysorbate 80, propylene glycol, tartaric acid, PVP, titanium dioxide, water, petrolatum, CMC, mineral oil

* Please review the disclaimer below.