Lidocore (single Unit Patch) Patch
FDA Label NDC 82944-103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ion Pharma, Llc for the product Lidocore (single Unit Patch) (NDC 82944-103). 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:, purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Lidocaine 4%

Purpose

Topical anesthetic

Warnings

  • For external use only

Otc - Do Not Use

Do not use:

  • More than one patch on your body at a time
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product.

Otc - When Using

When using this product:

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly.

Otc - Stop Use

Stop use and consult a doctor if:

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering.
  • Conditions worsen
  • Symptoms persist more than 7 days
  • Symptoms clear up and occur again within a few days.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding: 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.

Other Information:

  • Avoid storing product in direct sunlight.
  • Protect product from excessive moisture.

Principal Display Panel

NDC 82944-103-01

LIDOCORE
Lidocaine 4% Topical Anesthetic

TOPICAL PAIN PATCH
For Temporary Pain Relief

Flexible Patch Innovation

Soothing and Effective
Long Lasting Relief

1 PATCH
5.5 x 3.94 (14cm x 10cm)

APPLY FOR 8 HOURS

ION PHARMA

Lidocore (Lidocore 01)

Lidocore (Lidocore 01)

* Please review the disclaimer below.