SBC1 is a skin barrier emulsion indicated for management of dry, intact skin by maintaining a moist skin environment. SBC1 is comprised of a base cream (Prime Matter) mixed with milled silica-based fibers (SBF-1 and SBF-M1, described in MAF 3558), the same fibers used to make SiOxD Wound Matrix fibers (previously cleared in 510(k) submissions K222189, K232847, and K241660) to improve the texture of the cream. SBC1 is provided for prescription use only in 1- and 8-ounce jars for single patient use. The volumes offered in both container sizes are intended to be sufficient for multiple applications of the product to the treatment area(s) by a single patient.
A substance (e.g., cream, paste, ointment, gel, foam, or aerosol) intended to be applied to the skin/external mucosa (e.g., lips) to provide a protective moisture barrier to the external environment and/or to soften and sooth the skin. It is typically used for conditions such as dry, itchy, flaky, cracked, denuded, irritated or sun-damaged skin, cheilitis, and/or herpetic skin lesions. It may be intended for sensitive areas (e.g., areolar, perianal, lips, ears), dry skin and/or deep fissures (e.g., on the feet); it may include a disposable applicator. After application, this device cannot be reused.
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