SiOxC Cream

SiOxC Cream is a non-sterile, topical skin emulsion indicated for management of pruritus and dryness associated with atopic dermatitis and allergic contact dermatitis. It is a water-based formulation containing emollients, humectants, and a proprietary amorphous hydrated silica that promotes a moist environment. The product is prescription-only and available in 1 or 8 fl oz jars.

Both the subject device and predicate (EPICERAM) are non-sterile creams that promote a moist environment as their principle of operation, applied twice daily as needed. Both use phenoxyethanol as a preservative and are biocompatible. The subject device uses a proprietary amorphous hydrated silica formulation, while the predicate uses a proprietary lipid delivery system. Available sizes differ (1 or 8 fl oz jar versus 90g tube or 225g airless pump).

ISO 10993-1 (biocompatibility framework), ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (sensitization and irritation), ISO 10993-23 (temporary contact with skin), USP <51> (preservative effectiveness testing). Human Repeat Insult Patch Test (HRIPT) was performed to assess dermal irritation and sensitization potential.

The devices share the same intended use (management of dry skin in dermatitis conditions), identical principle of operation (promoting a moist environment), and similar technological characteristics including reapplication frequency, sterility status, and preservative system. Minor compositional differences (amorphous silica versus lipid delivery system) and packaging variations are addressed through biocompatibility testing and non-clinical performance data. Human testing demonstrated 100% of subjects had no visible skin reaction in both induction and challenge phases, establishing safety parity with the predicate device.