ADVERSE REACTIONS SECTION.

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.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis, Impairment of Fertility. Long-term animal studies to determine carcinogenic potential have not been performed. In vitro studies have shown no mutagenic activity.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Sulconazole nitrate is an imidazole derivative with broad-spectrum antifungal activity that inhibits the growth in vitro of the common pathogenic dermatophytes including Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis. It also inhibits (in vitro) the organism responsible for tinea versicolor, Malassezia furfur. Sulconazole nitrate has been shown to be active in vitro against the following microorganisms, although clinical efficacy has not been established: Candida albicans and certain gram-positive bacteria.A modified Draize test showed no allergic contact dermatitis and phototoxicity study showed no phototoxic or photoallergic reaction to sulconazole nitrate cream. Maximization tests with sulconazole nitrate cream showed no evidence of contact sensitization or irritation.

CLINICAL STUDIES SECTION.

CLINICAL STUDIES. In vehicle-controlled study for the treatment of tinea pedis (moccasin type) due to T. rubrum, after to weeks of treatment 69% of patients on the active drug and 19% of patients on the drug vehicle had become KOH- and culture-negative. In addition, 68% of patients on the active drug and 20% of patients on the drug vehicle showed good or excellent clinical response.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is contraindicated in patients who have history of hypersensitivity to any of its ingredients.

DESCRIPTION SECTION.

DESCRIPTION. EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is 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--[(p-cholorobenzyl)thio] phenethyl]imidazole mononitrate and it has the following chemical structure:Sulconazole nitrate, USP is white to off-white crystalline powder with 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 melting point of about 130C.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.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. 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 weeks and tinea pedis for weeks to reduce the possibility of recurrence.If significant clinical improvement is not seen after to weeks of treatment, an alternate diagnosis should be considered.

GENERAL PRECAUTIONS SECTION.

General. EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is for external use only. Avoid contact with the eyes. If irritation develops, the cream should be discontinued and appropriate therapy instituted.

GERIATRIC USE SECTION.

Geriatric Use. Clinical studies of EXELDERM CREAM, 1.0%, did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.

HOW SUPPLIED SECTION.

HOW SUPPLIED. EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is smooth, glossy white to off-white cream having slight characteristic odor. It is supplied as follows: 60 tube NDC 69489-711-60Avoid excessive heat, above 40 (104 F).To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. JOURNEY(R) MEDICAL CORPORATIONManufactured for:Journey Medical Corp. Scottsdale, AZ 85258 www.JMCderm.com141036Revised February 2019.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is an antifungal agent indicated for the treatment of tinea pedis (athletes 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.

INFORMATION FOR PATIENTS SECTION.

Information for Patients. Patients should be told to use EXELDERM CREAM as directed by the physician, to use it externally only, and to avoid contact with the eyes.

NURSING MOTHERS SECTION.

Nursing Mothers. It is not known whether sulconazole nitrate is excreted in human milk. Caution should be exercised when sul- conazole nitrate is administered to nursing woman.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Principal Display Panel 10 mg Carton Label. Exelderm(R)(sulconazole nitrate, USP) Cream, 1.0%Net Wt. 60 gNDC 69489-711-60JOURNEYMEDICAL CORPORATION. Principal Display Panel 10 mg Carton Label.

PEDIATRIC USE SECTION.

Pediatric Use. Safety and effectiveness in children have not been established.Efficacy for this organism in the organ system was studied in fewer than 10 infections.

PRECAUTIONS SECTION.

PRECAUTIONS. General. EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is for external use only. Avoid contact with the eyes. If irritation develops, the cream should be discontinued and appropriate therapy instituted.. Information for Patients. Patients should be told to use EXELDERM CREAM as directed by the physician, to use it externally only, and to avoid contact with the eyes.. Carcinogenesis, Mutagenesis, Impairment of Fertility. Long-term animal studies to determine carcinogenic potential have not been performed. In vitro studies have shown no mutagenic activity.. Pregnancy (Category C). There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if clearly needed. Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses of 125 times the adult human dose (in mg/kg). The drug was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day.Sulconazole nitrate given orally to rats at dose 125 times the human dose resulted in prolonged gestation and dystocia. Several females died during the prenatal period, most likely due to labor complications.. Nursing Mothers. It is not known whether sulconazole nitrate is excreted in human milk. Caution should be exercised when sul- conazole nitrate is administered to nursing woman.. Pediatric Use. Safety and effectiveness in children have not been established.Efficacy for this organism in the organ system was studied in fewer than 10 infections.. Geriatric Use. Clinical studies of EXELDERM CREAM, 1.0%, did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.

PREGNANCY SECTION.

Pregnancy (Category C). There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if clearly needed. Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses of 125 times the adult human dose (in mg/kg). The drug was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day.Sulconazole nitrate given orally to rats at dose 125 times the human dose resulted in prolonged gestation and dystocia. Several females died during the prenatal period, most likely due to labor complications.

SPL UNCLASSIFIED SECTION.

(sulconazole nitrate, USP) Cream, 1.0%Rx onlyFor topical use only. Not for ophthalmic use.