Device Dossier
Nail treatment solution
Device Dossier for Nail treatment solution (Nail treatment solution, Class IIa, sponsor Arrotex Pharmaceuticals). ARTG record, intended purpose, GMDN…
- GMDN category: Nail treatment solution
- Sponsor: Arrotex Pharmaceuticals
Intended purpose
A non-sterile topical solution in a plastic applicator with a silicone drop tip for application to nails. It promotes healing of discoloured & deformed nails (onychodystrophy) due to onychomycosis or psoriasis. It hydrates & smooths the outer layers of the nail plate & changes the nail's microenvironment (low pH, altered osmotic environment) to create an antagonistic environment for microorganisms & improves nail surface integrity, creating a barrier which prevents growth of fungi & bacteria.