Re-lieved 4% Lidocaine Fabric Tape Patch
FDA Label NDC 71662-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Transfer Technology for the product Re-lieved 4% Lidocaine Fabric Tape (NDC 71662-002). 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, use, warnings, do not use, otc - when using, otc - ask doctor/pharmacist, pregnancy, 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 Analgesic

Use

For the temporary relief of pain

Warnings

For external use only

Do Not Use

If you are allergic to Lidocaine. On open wounds or on damaged broken or irritated skin

Remove immediately if you sense a burning sensation after application

Ask your doctor or pharmacist before use if you are using blood thining medication, steroids, or non-steroidal anti-inflammatory drugs (NSAIDS), or if you have sensitive skin.

Otc - When Using

When using this product

  • do not use other topical products
  • Do not allow contact with eyes or mucous membranes
  • Keep away from excessive heat. Do not apply heating pad to areea of use
  • Apply only to clean, dry, and untreated skin.
  • Use only as directed. Read and follow all directions and warnings on this label

Otc - Ask Doctor/Pharmacist

Stop use or ask a doctor if

  • Condition worsens
  • Symptons persist for more than 7 days

Pregnancy

If pregnant or breastfeeding ask a physican before use.

Keep out of reach of children. If put in mouth, get medical help or contact a poison control center right away. Dispose of used product away from children and pets.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If put in mouth, get medical help or contact a poison control center right away.

Dosage & Administration

Directions adults and children 12 years or older

  • Peel patch off plastic liner and place patch over affected area.
  • Change patch 1 to 2 times a day.
  • Wash hands after applying patch
  • Under age 12 consult a physician before use

Other Safety Information

Other information

  • Store at room temperature
  • Do not exceed 100 o Fahrenheit 38 o Celsius
  • For easier removal of patch apply rubbing alcohol or baby oil to adhesive edge

Inactive Ingredient

Inactive ingredients: Acrylic adhesive, polyethylene foam

* Please review the disclaimer below.