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Below are the ingredient lists for the GeniCure device and Samaritan polymer
GeniCure Ingredient and Warnings
GeniCure's near-infrared light technology is based on the FDA-cleared ViruLite CS device, which is designed to treat hepes (herpes simplex labialis) by shortening healing time through the application of specific wavelengths of light.
The ViruLite CS device emits light energy at a near-infrared spectrum and is applied externally to the surface of herpes simplex labialis lesions.
Samaritan is a pure silicon based two part polymer.
Safety Statement
Complete Safety Assurance:
This two-part silicone polymer system is engineered with biocompatibility and safety in mind, making it suitable for medical applications. The ingredients are inert, non-toxic, and compliant with all relevant safety and environmental regulations.
Non-Hazardous Composition:
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Polydimethylsiloxane (PDMS) is widely recognized for its stability, hypoallergenic nature, and resistance to biological degradation.
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The platinum catalyst used in Part B is encapsulated for precise curing activity and does not pose any known health risks.
Safety Certifications:
This formulation adheres to ISO 10993-1 for biological evaluation of medical devices, ensuring compatibility with skin and other tissues. No harmful volatile organic compounds (VOCs) are released during or after curing.
Usage Guidelines:
For best results and safety:
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Mix equal parts of Part A and Part B by weight or volume.
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Allow the mixture to cure at room temperature or under recommended conditions.
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Once cured, the polymer is a fully inert material with no residual catalyst or chemical activity.
Warning:
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Do not leave on skin past 29 days
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Store in a cool, dry place away from direct sunlight.
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