Lidocore Patch
FDA Label NDC 82944-100

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 (NDC 82944-100). 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, uses:, warnings:, otc - do not use, otc - when using, otc - stop use, 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 Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses:

For the temporary relief of pain

Warnings:

For external use only

Otc - Do Not Use

Do not use

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • or if you are allergic to any ingredients of this product

Otc - When Using

When using this product

  • use only as directed
  • avoid contact with eyes, mucous membranes or rashes
  • do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor if

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

  • Clean and dry the affected area
  • Open pouch and remove one patch
  • Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
  • Reseal pouch containing unused patches after each use
  • Remove patch from the skin after at most 8-hour application

    • Children under 12 years of age: consult a doctor

Other Information:

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

Principal Display Panel

NDC 82944-100-10

LIDOCORE
Lidocaine 4% Topical Anesthetic

TOPICAL PAIN PATCH
For Temporary Pain Relief

Flexible Patch Innovation

Soothing and Effective
Long Lasting Relief

MADE IN USA

Qty: 10 Flexible Patches

(5 per Resealable Pouch) x2

3 x 5 (7.62cm x 12.7cm)

ION PHARMA

Lidocore (Lidocore 01)

Lidocore (Lidocore 01)

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