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510(k) Data Aggregation
K Number
K113807Device Name
DEXERYL CREAM
Manufacturer
Date Cleared
2012-03-07
(75 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PIERRE FABRE MEDICAL DEVICES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DEXERYL™ Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. DEXERYL™ Cream provides a moist environment, which is beneficial to the healing process.
Device Description
DEXERYLTM Cream is a clean but non-sterile skin emollient designed to provide protection and a moist environment to the skin, which is beneficial to the healing process. DEXER YL™ Cream is an oil in water emulsion, consisting of >50% water with glycerin, white soft paraffin, liquid paraffin, and other common excipients. The device formulation therefore confers an emollient effect, softening and soothing the skin to help prevent dry skin, irritation and itching. DEXER YL™ Cream is a prescription device.
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