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510(k) Data Aggregation
K Number
K093544Device Name
TROPAZONE CR
Manufacturer
MIDLOTHIAN LABORATORIES
Date Cleared
2010-02-16
(91 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MIDLOTHIAN LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tropazone CR is for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 200 degree burns, including sunburns, and radiation dermatitis.
Device Description
Tropazone CR is a non-sterile, semi-viscous emulsion intended for topical application. It is presented as a prescription medication, requiring a physician's diagnosis of disease state prior to use. This product is formulated as an oil-in-water emulsion containing moisturizing ingredients to keep the area moist. The oil composition of Tropazone CR is composed of mineral oil, lecithin, fatty acids and a silicon-based organic polymer.
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K Number
K090337Device Name
TROPAZONE LOTION
Manufacturer
MIDLOTHIAN LABORATORIES
Date Cleared
2009-08-13
(184 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MIDLOTHIAN LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tropazone Lotion 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. It helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Device Description
Tropazone Lotion 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 polyacrylic acid polymer as the thickening agent. The oil composition of Tropazone lotion is composed of mineral oil, lecithin, fatty acids and a silicon-based organic polymer.
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