Lidocaine Patch
FDA Label NDC 50488-2004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alexso, Inc for the product Lidocaine (NDC 50488-2004). 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 physician:, keep out of reach of children and pets., 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

External analgesic

Uses

Temporarily relieves pain and itching associated with:

• minor burns

• sunburn

• minor cuts

• scrapes

• insect bites

• minor skin irritations

Warnings

For external use only.

Read all warnings and directions before use.

Do Not Use

• More than one patch at a time

• On wounds or damaged skin

• With a heating pad

• If you are allergic to any ingredients of this product

Allergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use.

When Using This Product

• Use only as directed. 

• Avoid contact with eyes, mucous membranes, or rashes

• Do not tightly wrap or bandage the treated area

Stop Use And Ask A Physician:

• If pregnant or breast feeding

• If localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Keep Out Of Reach Of Children And Pets.

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

Directions

Adults and children 12 years of age and older:

Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.

  • Clean and dry the affected area.
  • Open pouch and remove one patch.
  • Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
  • Wash hands with soap and water after handling the patches.
  • Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
  • Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

    • Children under 12 years: Ask a physician

Other Information

Store at room temperature 15°-30°C (59°-86°F)

Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive Ingredients

Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben, Peppermint Oil

Principal Display Panel

Lidocaine 4% Patch

NDC 50488-2004-1

10 Patches per Box

Alexso, Inc

Principal Display Panellidocaine 4% Patchndc 50488-2004-110 Patches Per Boxalexso, Inc (Lidocaine Patch 01)

Principal Display Panellidocaine 4% Patchndc 50488-2004-110 Patches Per Boxalexso, Inc (Lidocaine Patch 01)

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