Exelderm 10 mg/g
Sulconazole Nitrate · CREAM · Journey Medical Corporation
Exelderm is a cream containing sulconazole nitrate at 10 mg/g, taken topical. Manufactured by Journey Medical Corporation.
Key Facts
- Brand Name
- Exelderm
- Generic Name
- Sulconazole Nitrate
- NDC Code (Product)
69489-711- Manufacturer
- Journey Medical Corporation
- Strength
- 10 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA018737
- Marketing Start
- 06/07/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND 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
DOSAGE AND 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.
Contraindications
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
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.
Frequently Asked Questions
What is Exelderm used for?
Exelderm contains Sulconazole Nitrate. It is a cream taken topical. Consult your doctor for specific uses.
Is Exelderm a controlled substance?
Exelderm is not classified as a controlled substance by the DEA.
What is the generic name for Exelderm?
The generic name for Exelderm is Sulconazole Nitrate. There are 2 other brand versions of Sulconazole Nitrate.
What is the NDC code for Exelderm 10 mg/g?
The NDC (National Drug Code) for Exelderm 10 mg/g is 69489-711, listed by Journey Medical Corporation.