Welmate Lidocaine Pain Relieving Patch
FDA Label NDC 73581-911

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Welmate Lidocaine Pain Relieving Patch (NDC 73581-911). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For temporary relieves minor pain

Warnings

For external use only

Do Not Use

  • more than one patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients
  • if pouch is damaged or opened.

When Using This Product

  • use only as directed
  • read and follow directions and warnings on this carton
  • do not allow contact with eyes.
  • Do not use at the same time as other topical analgesics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • 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

  • conditions worsen
  • Redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

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 800-222-1222 right away.

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • carefully remove backing from patch starting at a corner.
  • Apply sticky side of patch to affected area.
  • Use one patch for up to 12 hours.
  • Discard patch after single use

    • Children under 12 years of age: consult a physician

Other Information

  • Store in a clean, dry place outside of direct sunlight
  • Protect from excessive moisture

Inactive Ingredients

aluminum glycinate, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

Questions Or Comments?

Toll free 866-933-6337 www.salonpas.us

* Please review the disclaimer below.