Dermalage

Dermalage is a liquid wound cleanser solution provided in a spray bottle for over-the-counter use. It is intended to cleanse wounds and remove foreign material such as debris and dirt from dermal wounds through mechanical action as the fluid moves across the wound bed. The solution is limited to single-patient use for up to 24 hours.

Dermalage is a non-sterile, non-buffered aqueous surfactant-based solution with density of 1 g/ml containing water, sorbitol, sodium laureth sulfate, sodium lauryl sulfoacetate, disodium laureth sulfosuccinate, cocamidopropyl betaine, Imidazolidinyl Urea (preservative), and sodium hydroxide. It is applied topically via spray bottle in multiple sizes (2oz, 4oz, 8oz) and functions through mechanical removal rather than chemical action.

ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Maximization and Intracutaneous Reactivity), ISO 10993-11 (Acute Toxicity and Pyrogenicity), USP <151> (Pyrogenicity), USP <51> (Antimicrobial Effectiveness), and toxicological risk assessment and shelf-life testing.

Both Dermalage and the predicate device (K103713 Elta Wound Cleanser) share the same product code (FRO), regulatory classification (Unclassified), intended use (over-the-counter wound cleansing), application method (spray bottles in multiple sizes), and mechanism of action (mechanical removal). Critically, both are surfactant-based solutions with identical preservative (Imidazolidinyl Urea) and common components (water, sorbitol), and both are non-sterile and non-buffered. Performance testing demonstrates Dermalage meets the same biocompatibility and antimicrobial effectiveness standards as the predicate, with differences in other formulation components not raising new safety or effectiveness questions.