Source: FDA, National Drug Code (US) Revision Year: 2019
EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in EXELDERM CREAM, is an imidazole derivative with in vitro antifungal and antiyeast activity.
Its chemical name is (±)1[2,4-Dichloro-β-[(p-cholorobenzyl)thio] phenethyl]imidazole mononitrate and it has the following chemical structure:
Sulconazole nitrate, USP 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 CREAM contains sulconazole nitrate, USP 10 mg/g in an emollient cream base consisting of propylene glycol, stearyl alcohol, isopropyl myristate, cetyl alcohol, polysorbate 60, sorbitan mono-stearate, glyceryl stearate (and) PEG-100 stearate, ascorbyl paImitate, and purified water, with sodium hydroxide and/or nitric acid added to adjust the pH.
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EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is a smooth, glossy white to off-white cream having a slight characteristic odor. It is supplied as follows: 60 g tube – NDC 69489-711-60 |
| Drug | Countries | |
|---|---|---|
| EXELDERM | Japan, United States |
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