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  5. Label Information: Lidonex

FDA Label for Lidonex

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. INACTIVE INGREDIENT
    9. STORAGE AND HANDLING
    10. OTC - QUESTIONS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidonex Product Label

The following document was submitted to the FDA by the labeler of this product Newpharma, Inc.. 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.

Otc - Active Ingredient



Active Ingredient

Lidocaine HCL, USP 4% 


Otc - Purpose



Purpose

Topical Anesthetic


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, menthol, methylparaben, propylparaben, purified water, xanthan gum


Otc - Questions



Questions or comments? (305) 592 - 9216


* Please review the disclaimer below.