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510(k) Data Aggregation
K Number
K052643Device Name
EPICERAM
Manufacturer
CERAGENIX CORPORATION
Date Cleared
2006-04-11
(197 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CERAGENIX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FOR TOPICAL DERMATOLOGICAL USE ONLY
EPICERAM® is a skin barrier emulsion to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, radiation dermatitis. EPICERAM® helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Apply Epiceram® in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin. If the skin is broken, cover Epiceram® with a dressing of choice.
Device Description
EPICERAM™ is a non-sterile, viscous, lipid-rich emulsion presented for prescription use.
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