Lidozen Gel
FDA Label NDC 63187-892

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Lidozen (NDC 63187-892). 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 ingredients:, otc - purpose, uses:, warnings:, keep out of reach of children., directions (adults and children over 12 years):, inactive ingredients:, package labeling:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Lidocaine HCL 4.00%

Menthol 1.00%

Otc - Purpose

Topical Anesthetic

External Analgesic

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):

Apply directly to affected area. Do not use more than four times per day.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbte-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5

Package Labeling:

63187-892-72 (Label)

63187-892-72 (Label)

Manufactured for:

Village Pharma LLC

Agoura Hills, CA 91301

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

* Please review the disclaimer below.