Lidopro Patch
FDA Label NDC 83881-403

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Clinic Pharma for the product Lidopro (NDC 83881-403). 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 ingredients (in each patch), purpose, use, warnings, do not use, when using this, stop use and consult a doctor if, if pregnant or breastfeeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Patch)

Lidocaine 4%

Menthol 1%

Purpose

External Anesthetic

External Analgesic

Use

Temporarily 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

  • 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 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 Consult A Doctor If

  • condition worsens 
  • 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 Breastfeeding,

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 1-800-222-1222 right away.

Directions

Adults and children 12 years of age and over: clean and dry affected area, free of lotions, ointments, and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12-hour period. Maximum 2 patches per day. 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

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid, polysorbate 80, povidone K90, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

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