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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
EXTINA® (ketoconazole) Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Safety and efficacy of EXTINA® Foam for treatment of fungal infections have not been established.
History
There is currently no drug history available for this drug.
Other Information
EXTINA® Foam contains 2% ketoconazole USP, an antifungal agent, in a thermolabile hydroethanolic foam for topical application.
The chemical name for ketoconazole is piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl) -2-(1H-imidazol-l-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, cis- with the molecular formula C26H28Cl2N4O4 and a molecular weight of 531.43. The following is the chemical structure:
EXTINA® Foam contains 20 mg ketoconazole per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.
Sources
Extina Manufacturers
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Prestium Pharma, Inc.
Extina | Prestium Pharma, Inc.
EXTINA® Foam should be applied to the affected area(s) twice daily for four weeks.
Hold the container upright, and dispense EXTINA® Foam into the cap of the can or other cool surface in an amount sufficient to cover the affected area(s). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of EXTINA® Foam with the fingertips, and gently massage into the affected area(s) until the foam disappears. For hair-bearing areas, part the hair, so that EXTINA® Foam may be applied directly to the skin (rather than on the hair).
Avoid contact with the eyes and other mucous membranes. EXTINA® Foam is not for ophthalmic, oral or intravaginal use.
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