Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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 Avoid excessive heat, above 40° C (104° F). To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. JOURNEY ® MEDICAL CORPORATION Manufactured for: Journey Medical Corp. Scottsdale, AZ 85258 www.JMCderm.com 141113 Revised March 2021; Principal Display Panel – 60 g Carton Label Exelderm ® (sulconazole nitrate, USP) Cream, 1.0% NDC 69489-711-60 Net Wt. 60 g JOURNEY MEDICAL CORPORATION 60 gram Carton Label; Principal Display Panel – 60 gram Tube Label Exelderm ® (sulconazole nitrate, USP) Cream, 1.0% Avoid excessive heat, above 40°C (104° F). NDC 69489-711-60 Rx only Net Wt. 60 g For topical use only. Not for ophthalmic use. 60 gram Tube Label
- HOW SUPPLIED 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 Avoid excessive heat, above 40° C (104° F). To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. JOURNEY ® MEDICAL CORPORATION Manufactured for: Journey Medical Corp. Scottsdale, AZ 85258 www.JMCderm.com 141113 Revised March 2021
- Principal Display Panel – 60 g Carton Label Exelderm ® (sulconazole nitrate, USP) Cream, 1.0% NDC 69489-711-60 Net Wt. 60 g JOURNEY MEDICAL CORPORATION 60 gram Carton Label
- Principal Display Panel – 60 gram Tube Label Exelderm ® (sulconazole nitrate, USP) Cream, 1.0% Avoid excessive heat, above 40°C (104° F). NDC 69489-711-60 Rx only Net Wt. 60 g For topical use only. Not for ophthalmic use. 60 gram Tube Label
Overview
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 -chlorobenzyl)-thiol]-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. Chemical Structure
Indications & Usage
EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is an antifungal agent indicated for the treatment of tinea pedis (athlete's foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagro-phytes, Epidermophyton floccosum, and Microsporum canis,* and for the treatment of tinea versicolor. *Efficacy for this organism in the organ system was studied in fewer than ten infections.
Dosage & Administration
A small amount of cream should be gently massaged into the affected and surrounding skin areas once or twice daily, except in tinea pedis, where administration should be twice daily. Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, tinea corporis/cruris and tinea versicolor should be treated for 3 weeks and tinea pedis for 4 weeks to reduce the possibility of recurrence. If significant clinical improvement is not seen after 4 to 6 weeks of treatment, an alternate diagnosis should be considered.
Warnings & Precautions
No warnings available yet.
Contraindications
EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of its ingredients.
Adverse Reactions
There were no systemic effects and only infrequent cutaneous adverse reactions in 1185 patients treated with sulconazole nitrate cream in controlled clinical trials. Approximately 3% of these patients reported itching, 3% burning or stinging, and 1% redness. These complaints did not usually interfere with treatment.
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