SiOxC

Basic Information

• Brand Name: SiOxC
• Primary DI: 00850021883034
• Version / Model: SiOxC Cream 8 Oz 1 Unit
• Catalog Number: EDS-11019
• Company Name: Sioxmed, LLC
• Labeler DUNS: 035978729
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-10
• Public Version: 2
• Public Version Date: 2026-01-22
• Public Version Status: Update
• Public Device Record Key: 76d83312-fa67-43fc-9897-6ab5f577c956

Device Description

SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for management of dry skin. SiOxC Cream supports a moist skin environment. SiOxC Cream is provided prescription only in various sizes for single patient use. Indications for use: SiOxC Cream is a skin emulsion indicated for management of pruritus and dryness of skin in atopic dermatitis and allergic contact dermatitis. Not to be used on Breached or Compromised skin or open sores. Specifically, SiOxC Cream contains milled amorphous silica fibers that are highly absorbent, retain moisture, and promote a moist environment. These fibers are not absorbed into the skin. As desired, any residual fibers may be removed from the skin after the cream is absorbed. SiOxC Cream is provided prescription only in various sizes for single patient use

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46206	Dry skin moisture barrier dressing	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850021883034	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K242406	000