Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED SULCONAZOLE NITRATE topical solution 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows: 30 mL plastic bottle – NDC 72143-321-30 Avoid excessive heat, above 40° C (104° F), and protect from light. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. JG Pharma Manufactured for: JG Pharma Scottsdale, AZ 85258 www.JGPharminc.com 141078 September 2019; Principal Display Panel – 30 mL Carton NDC 72143-321-30 sulconazole nitrate topical solution , 1.0% 30 mL Rx only For topical use only. Not for ophthalmic use. JG Pharma 30 mL Carton PDP; Principal Display Panel – 30 mL Bottle Label sulconazole nitrate topical solution , 1.0% Rx only For topical use only. Not for ophthalmic use. 30 mL 30 mL Bottle label PDP
- HOW SUPPLIED SULCONAZOLE NITRATE topical solution 1.0% is a clear, slightly viscous, colorless to slightly yellow liquid with a slight characteristic odor. It is supplied as follows: 30 mL plastic bottle – NDC 72143-321-30 Avoid excessive heat, above 40° C (104° F), and protect from light. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. JG Pharma Manufactured for: JG Pharma Scottsdale, AZ 85258 www.JGPharminc.com 141078 September 2019
- Principal Display Panel – 30 mL Carton NDC 72143-321-30 sulconazole nitrate topical solution , 1.0% 30 mL Rx only For topical use only. Not for ophthalmic use. JG Pharma 30 mL Carton PDP
- Principal Display Panel – 30 mL Bottle Label sulconazole nitrate topical solution , 1.0% Rx only For topical use only. Not for ophthalmic use. 30 mL 30 mL Bottle label PDP
Overview
SULCONAZOLE NITRATE topical solution 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in SULCONAZOLE NITRATE topical solution, is an imidazole derivative with 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. SULCONAZOLE NITRATE topical solution contains sulconazole nitrate, USP 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. chemical structure
Indications & Usage
SULCONAZOLE NITRATE topical solution 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). Symptomatic relief usually occurs within a few days after starting SULCONAZOLE NITRATE topical solution and clinical improvement usually occurs within one week.
Dosage & Administration
A small amount of solution should be gently massaged into the affected and surrounding skin areas once or twice daily. Symptomatic relief usually occurs within a few days after starting SULCONAZOLE NITRATE topical solution 1.0%, and clinical improvement usually occurs within 1 week. To reduce the possibility of recurrence, tinea cruris, tinea corporis, and tinea versicolor should be treated for 3 weeks. If significant clinical improvement is not seen after 4 weeks of treatment, an alternate diagnosis should be considered.
Warnings & Precautions
No warnings available yet.
Contraindications
SULCONAZOLE NITRATE topical solution 1.0% is contraindicated in patients who have a history of hypersensitivity to any of the ingredients.
Adverse Reactions
There were no systemic effects and only infrequent cutaneous adverse reactions in 370 patients treated with sulconazole nitrate solution in controlled clinical trials. Approximately 1% of these patients reported itching and 1% burning or stinging. These complaints did not usually interfere with treatment.
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