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510(k) Data Aggregation
K Number
K120730Device Name
LOUTREX TOPICAL CREAM
Manufacturer
ACELLA PHARMACEUTICALS, LLC
Date Cleared
2012-09-06
(181 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ACELLA PHARMACEUTICALS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional, Loutrex Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling, and pain. Loutrex Topical Cream helps relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Device Description
Loutrex Topical Cream is a non-sterile, white to off-white water based emulsion intended for topical application applied 3 times per day or as needed. It is presented as a Prescription (requires a physician diagnosis of disease state) for use.
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