Lidonex Liquid
FDA Label NDC 73564-804

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aldama Pharmaceuticals, Inc for the product Lidonex (NDC 73564-804). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Lidocaine HCL, USP 4%

Menthol USP 5%

Otc - Purpose

Purpose

Topical Anesthetic

Pain Relieving

Indications & Usage

Use

For temporarily relief of pain

Warnings

Warnings

For external use only

Flammable: Keep away from fire or flame

Do not use

  • on wounds or damaged skin
  • in large quantaties
  • with a heating pad
  • if you are allergic to any ingredients of this product

    • When using this product

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

      • Stop use and ask doctor if

      • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
      • condition worsens
      • 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.

Dosage & Administration

Directions

Adults and children over 12 years of age and over

  • clean and dry affected area
  • apply to affected area not more than 3 to 4 times daily

    • Children under 12 years of age:Consult a doctor

Inactive Ingredient

Inactive ingredients

glycerin, isopropyl alcohol, methylparaben, propylparaben, purified water, xanthan gum

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