Theracare Pain Relief 4% Lidocaine Patch
FDA Label NDC 71101-059

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Theracare Pain Relief 4% Lidocaine (NDC 71101-059). 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 relief of pain

Warnings

For external use only

Do Not Use

  • more than one patch on your body at a time
  • on cut 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 all directions and warnings on this carton
  • Do not allow contact with the 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 a used patch in a manner that always keeps the 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 ingest 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 an 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 the backing from the patch starting at a corner
  • Apply the sticky side of patch to the 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

dihydroxy aluminium aminoacetate, disodium EDTA, glycerin, methyl paraben, polyacrylic acid, polyvinyl alcohol, propyl paraben, propylene glycol, sodium carboxy methyl cellulose, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions Or Comments?

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