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510(k) Data Aggregation
K Number
K173549Device Name
BIAFINE
Manufacturer
Valeant Pharmaceuticals
Date Cleared
2018-08-13
(270 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Valeant Pharmaceuticals
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTC Indications and Usage: BIAFINE is indicated for management of superficial wounds such as minor scrapes, minor irritations, minor abrasions, minor blisters, 1st degree burns, minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, abrasions and minor burns. RX Indications and Usage: BIAFINE is indicated for management of full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers, radiation dermatitis, donor sites and 2nd degree burns. BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, abrasions and minor burns.
Device Description
BIAFINE Topical Cream is a white oil-in-water cream and is supplied in lined aluminum tubes with a screw-top closure. Ingredients: Purified water, liquid paraffin, ethylene glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalane, avocado oil, trolamine/sodium alginate, triethanolamine, cetyl palmitate, methylparaben (sodium salt), sorbic acid (as potassium salt), propyl paraben (sodium salt), and fragrance.
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