Drugplain

Sulconazole Nitrate 10 mg/g

Sulconazole Nitrate · CREAM · JG Pharma

No Recall HistoryCurrently in Shortage
Plain English

Sulconazole Nitrate is a cream containing sulconazole nitrate at 10 mg/g, taken topical. Manufactured by JG Pharma.

Key Facts

Brand Name
Sulconazole Nitrate
Generic Name
Sulconazole Nitrate
NDC Code (Product)
72143-311
Manufacturer
JG Pharma
Strength
10 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
NDA018737
Marketing Start
02/04/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death1 reports
dermatitis atopic1 reports
jaundice1 reports
liver function test abnormal1 reports
nausea1 reports
ocular hyperaemia1 reports
pruritus1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE SULCONAZOLE NITRATE 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.

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 SULCONAZOLE NITRATE 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 Sulconazole Nitrate used for?

Sulconazole Nitrate contains Sulconazole Nitrate. It is a cream taken topical. Consult your doctor for specific uses.

Is Sulconazole Nitrate a controlled substance?

Sulconazole Nitrate is not classified as a controlled substance by the DEA.

What is the generic name for Sulconazole Nitrate?

The generic name for Sulconazole Nitrate is Sulconazole Nitrate. There are 2 other brand versions of Sulconazole Nitrate.

What is the NDC code for Sulconazole Nitrate 10 mg/g?

The NDC (National Drug Code) for Sulconazole Nitrate 10 mg/g is 72143-311, listed by JG Pharma.

Product NDC

72143-311

Package NDC

72143-311-60

Other Sulconazole Nitrate Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)