SiOxC EDS-11016

GUDID 00850021883027

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

Sioxmed, LLC

Dry skin moisture barrier dressing

• Primary Device ID: 00850021883027
• NIH Device Record Key: 666ccc00-f16d-4e7c-87a2-a6074099dbe5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SiOxC
• Version Model Number: SiOxC Cream 1 Oz 1 Unit
• Catalog Number: EDS-11016
• Company DUNS: 035978729
• Company Name: Sioxmed, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850021883027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242406

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-22
• Device Publish Date: 2025-11-10

On-Brand Devices [SiOxC]

• 00850021883034: SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for
• 00850021883027: SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for
• 00850021883065: SBC1 is a skin barrier emulsion indicated for management of dry, intact skin by maintaining a mo
• 00850021883058: SBC1 is a skin barrier emulsion indicated for management of dry, intact skin by maintaining a mo