FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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 Ketoconazole Foam, 2% for treatment of fungal infections have not been established.
History
There is currently no drug history available for this drug.
Other Information
Ketoconazole Foam, 2% 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-1-ylmethyl)-1, 3-dioxolan-4-yl]methoxy]phenyl]-, cis- with the molecular formula C26H28CI2N4O4 and a molecular weight of 531.43.
The following is the chemical structure:
Ketoconazole Foam, 2% contains 20 mg ketoconazole USP per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol NF, citric acid USP, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60 NF, potassium citrate USP, propylene glycol USP, purified water USP, and stearyl alcohol NF pressurized with a hydrocarbon (propane/butane) propellant.
Sources
Ketoconazole Aerosol Manufacturers
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Perrigo New York Inc
Ketoconazole Aerosol | Save-a-lot Food Stores Ltd
• do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of ageage
dose
adults and children 12 years and over
10 mL every 4 hours
children under 12 years
do not use
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