Device Dossier

Nail treatment solution

Device Dossier for Nail treatment solution (Nail treatment solution, Class IIa, sponsor Actor Pharmaceuticals). ARTG record, intended purpose, GMDN…

Intended purpose

A non-sterile topical solution designed to treat infected nails (e.g.,onychomycosis) and nail-growth disorders (onychodystrophy) by creating a barrier to and an antagonistic environment for microorganisms. The solution is delivered onto the nail plate, which will penetrate through, and is applied until a completely healthy nail has grown. It controls the microenvironment of the nail by acidifying the nail bed; contains acidic substances that are able to penetrate the nail and permit treatment from the inside out; and immediately lowers the pH of the nail, creating an environment that is hostile to fungal growth.

TGA Public Summary