Lenzagel
FDA Label NDC 53217-026
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aidarex Pharmaceuticals Llc for the product Lenzagel (NDC 53217-026). 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 lenzagel, active ingredients:, purpose, uses:, warnings, keep out of reach of children., directions, other ingredients:, 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%
Purpose
Topical Analgesic
External Analgesic
Uses:
For temporary relief of pain associated with minor cuts, scrapes and minor skin irritations.
Warnings
- For external use only
- Avoid contact with eyes
- Do not apply to open wounds or damaged skin.
- If symptoms persist for more than seven days, discontinue use and consult physician.
Keep Out Of Reach Of Children.
If swallowed, consult physician.
Directions
- Apply directly to effected area. Do not use more than four times per day.
Other 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, Polysorbate-80, Sodium Lauryl Sulfate, Triethanolamine, FD C Blue 1, FD C Yellow 5.
Package Label Principal Display Panel
Image Label (Lenzagel 120 Gm For Pharmaceutica North America 1)
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880
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