FDA Label for Lidozen

View Indications, Usage & Precautions

Lidozen Product Label

The following document was submitted to the FDA by the labeler of this product Village 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 HCL 4.00%

Menthol 1.00%


Uses:



For temporary relief of pain


Warnings:



  • For external use only.
  • Avoid contact with eyes.
  • 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.

Do Not Use



in large quantities, particularly over raw surfaces or blistered areas.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



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


Directions (Adults And Children Over 12 Years):



Clean and dry affected area.

Remove patch from backing and apply to affected area.

Use only one patch at a time, and maximum of four patches / day.

Leave patch on affected area for up to 8 hours.

Do not use patches for longer than five consective days.

Children under 12 should consult physician prior to use.


Inactive Ingredients:



Propylene Glycol, Carboxymethyl Cellulose Sodium, Dihydroxyaluminum Aminoacetate, Ethanol, Glycerin, Kaolin, Partially Neutralized Polyacrylate, Polysorbate 80, Polyvinylpyrrolidone 90, Tartaric Acid, Tetrasodium Edetate, Titanium Dioxide, Hydrogenated Castor Oil, Phenoxyethanol, Urea, Water.


Package Labeling:




* Please review the disclaimer below.