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(sulconazole nitrate) Solution, 1.0%
For topical use only. Not for ophthalmic use.
EXELDERM (sulconazole nitrate) SOLUTION, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, the active ingredient in EXELDERM (sulconazole) SOLUTION, is an imidazole derivative with antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-Dichloro-β [( p-chlorobenzyl)thio]phenethyl] imidazole mononitrate and it has the following chemical structure:
Sulconazole nitrate is a white to off-white crystalline powder with a molecular weight of 460.77. It is freely soluble in pyridine; slightly soluble in ethanol, acetone, and chloroform; and very slightly soluble in water. It has a melting point of about 130°C.
EXELDERM SOLUTION contains sulconazole nitrate 10 mg/mL in a solution of propylene glycol, poloxamer 407, polysorbate 20, butylated hydroxyanisole, and purified water, with sodium hydroxide and, if necessary, nitric acid added to adjust the pH.
What are the possible side effects of sulconazole topical (Exelderm)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using sulconazole topical and call your doctor at once if you have severe blistering, itching, redness, peeling, dryness, or irritation of treat skin areas.
Less serious side effects may include mild skin dryness or irritation.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...
What are the precautions when taking sulconazole (Exelderm)?
Before using sulconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, ketoconazole, or miconazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history.
This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before...
Last reviewed on RxList: 7/23/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Exelderm Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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