Auvon Pain Relief
FDA Label NDC 83391-006

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 Pain Relief (NDC 83391-006). 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 auvon lidocaine pain relief patch, active ingredients, purposes, use, warnings, do not use, stop use and ask a doctor, 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

Auvon Lidocaine Pain Relief Patch

Drug Facts

Active Ingredients

Lidocaine HCl 4%

Purposes

Topical Analgestic

Use

Temporarily relieves minor pain

Warnings

For external use only

Please read all directions and warnings as follows and use only as directed. 

Do not use in large quantities, particularly over raw surfaces or blistered areas

Do Not Use

  • Alone if you are under 12 years of age, please consult a doctor
  • If you are allergic to the listed ingredients
  • If the package arrives damaged or opened
  • On cuts, puncture wounds, and damaged, broken, swollen, or irritated skin
  • On eyes and mucous membranes
  • More than one patch on your body at a time or with other topical analgesics at the same time
  • Tightly wrapped or localized heat (e.g. heating pads) in the area of use.

Stop Use And Ask A Doctor

  • if symptoms persist for more than 7 days or clear up and occur again within a few days
  • If you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering

Otc - Keep Out Of Reach Of Children

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children and pets.If swallowed, 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.
  • Wash hands with cool water after use
  • Cutting first if used on joints
  • Do not repeatedly use or reapply the patch as far as possible
  • Apply to affected area not more than 3-4 times daily

Storage

  • Avoid storing patches in direct sunlight
  • Protect patches from excessive moisture
  • Please store it at room temperature 20-25 C (68-77F)

Inactive Ingredients

Dihydroxyaluminum aminoacetate, Glycerin, Kaolin, Methylparaben, Polyacrylic acid, Polysorbate 80, Propylene glycol, Water, Propylparaben, PVP, Sodium polyacrylate, Tartaric acid, Titanium Dioxide, Water

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