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510(k) Data Aggregation
K Number
K083721Device Name
MODIFICATION TO ZENIEVA
Manufacturer
RIVER'S EDGE PHARMACEUTICALS, LLC
Date Cleared
2009-01-08
(24 days)
Product Code
NAE
Regulation Number
878.4022Why did this record match?
Applicant Name (Manufacturer) :
RIVER'S EDGE PHARMACEUTICALS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Device Description
Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a cross-linked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.
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