FDA Label for Re-lieved 4% Lidocaine Fabric Tape

View Indications, Usage & Precautions

Re-lieved 4% Lidocaine Fabric Tape Product Label

The following document was submitted to the FDA by the labeler of this product Transfer Technology. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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