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  5. Label Information: Lidocore

FDA Label for Lidocore

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES:
    4. WARNINGS:
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION:
    12. PRINCIPAL DISPLAY PANEL

Lidocore Product Label

The following document was submitted to the FDA by the labeler of this product Ion Pharma, Llc. 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 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


* Please review the disclaimer below.