SiOxC

Primary DI
00850021883034
Brand
SiOxC
Company
Sioxmed, LLC
Model
SiOxC Cream 8 Oz 1 Unit
Catalog number
EDS-11019
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
Published
2025-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242406000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242406000SiOxC CreamSioxmed, LLC2025-03-13FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850021883034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850021883034008500218830348500218830340850021883034

GMDN Terms#

Term, Definition table
TermDefinition
Dry skin moisture barrier dressingA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3365512209support@sioxmed.com

Regulatory Flags#

DUNS number
035978729
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850021883072SiOxD® ORSiOxD® OR Wound Matrix, 1gEDS-100502026-03-17
00850021883058SiOxCSBC1, 1 Oz, 1 UnitEDS-140012026-01-21
00850021883065SiOxCSBC1, 8 Oz, 1 UnitEDS-140022026-01-21
00850021883027SiOxCSiOxC Cream 1 Oz 1 UnitEDS-110162025-11-10
00850021883003SiOxD Wound MatrixSiOxD 0.3g 2.5in Round (0.35in) 1 Unit MylarEDS-100622025-11-10
00850021883041SiOxD Wound MatrixUniversal Combat Matrix (UCM) 0.7g 2.5in Round (0.EDS-130012025-11-10
10850021883000SiOxD Wound MatrixEDS-10058EDS-100582025-02-17

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