NDC 72143-311 Sulconazole Nitrate

Sulconazole Nitrate

NDC Product Code 72143-311

NDC CODE: 72143-311

Proprietary Name: Sulconazole Nitrate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sulconazole Nitrate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Sulconazole is used to treat skin infections such as jock itch and ringworm. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Sulconazole is an azole antifungal that works by preventing the growth of fungus.

NDC Code Structure

  • 72143 - Jg Pharma

NDC 72143-311-60

Package Description: 1 TUBE in 1 CARTON > 60 g in 1 TUBE

NDC Product Information

Sulconazole Nitrate with NDC 72143-311 is a a human prescription drug product labeled by Jg Pharma. The generic name of Sulconazole Nitrate is sulconazole nitrate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Jg Pharma

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sulconazole Nitrate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SULCONAZOLE NITRATE 10 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • NITRIC ACID (UNII: 411VRN1TV4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Azole Antifungal - [EPC] (Established Pharmacologic Class)
  • Azoles - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Jg Pharma
Labeler Code: 72143
FDA Application Number: NDA018737 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-04-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Sulconazole Topical

Sulconazole Topical is pronounced as (sul kon' na zole)

Why is sulconazole topical medication prescribed?
Sulconazole is used to treat skin infections such as athlete's foot (cream only), jock itch, and ringworm.This medication is sometimes prescribed for other uses; ask your...
[Read More]

* Please review the disclaimer below.

Sulconazole Nitrate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx onlyFor topical use only. Not for ophthalmic use.

Description

SULCONAZOLE NITRATE cream 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in SULCONAZOLE NITRATE cream, is an imidazole derivative with in vitro antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-Dichloro-β-[(p-chlorobenzyl)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 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 monostearate, glyceryl stearate (and) PEG-100 stearate, ascorbyl palmitate, and purified water, with sodium hydroxide and/or nitric acid added to adjust the pH.

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 mentagro- phytes, 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 a 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.

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.

Contraindications

SULCONAZOLE NITRATE cream 1.0% is contraindicated in patients who have a history of hypersensitivity to any of its ingredients.

General

SULCONAZOLE NITRATE 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 SULCONAZOLE NITRATE 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

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 a 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 a nursing woman.
*Efficacy for this organism in the organ system was studied in fewer than 10 infections.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Clinical studies of SULCONAZOLE NITRATE 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.

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.

Clinical Studies

In a vehicle-controlled study for the treatment of tinea pedis (moccasin type) due to T. rubrum, after 4 to 6 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 a good or excellent clinical response.

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.

How Supplied

SULCONAZOLE NITRATE 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 72143-311-60
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.
Manufactured for:JG Pharma Scottsdale, AZ 85258www.JGPharmainc.com
141079September 2019

* Please review the disclaimer below.