Lidocaine Pain Relieving Patch
FDA Label NDC 68001-625

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bluepoint Laboratories for the product Lidocaine Pain Relieving Patch (NDC 68001-625). 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, otc - pregnancy 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 the temporary relief of pain

Warnings:

For external use only.

Do Not Use

  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product

When Using This Product

  • Use only as directed
  • Do not bandage tightly
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not apply to open wounds or damaged skin

Stop Use And Ask A Doctor If

  • Condition worsens
  • Symptoms persist for more than 7 days or clears up and occurs again within a few days
  • Severe burning sensation, redness or irritation develops
  • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep Out of Reach of Children and Pets. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: do not use, consult a physician.

  • Clean and dry affected area
  • Remove the film from the patch and apply to the affected area
  • Use 1 patch at a time and not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8 hours application

* Please review the disclaimer below.