Exelderm

Sulconazole Nitrate

Journey Medical Corporation
Human Prescription Drug
NDC 69489-721

Exelderm also known as Sulconazole Nitrate is a human prescription drug labeled by 'Journey Medical Corporation'. National Drug Code (NDC) number for Exelderm is 69489-721. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Exelderm drug includes Sulconazole Nitrate - 10 mg/mL . The currest status of Exelderm drug is Active.

Drug Information:

Drug NDC:	69489-721
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Exelderm
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Sulconazole Nitrate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Journey Medical Corporation
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	SULCONAZOLE NITRATE - 10 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	07 Jun, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	30 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	NDA018738
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Journey Medical Corporation
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	208118 313125
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	1T89100D5U
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Azole Antifungal [EPC] Azoles [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
69489-721-05	5 mL in 1 BOTTLE (69489-721-05)	15 Mar, 2021	N/A	Yes
69489-721-30	1 BOTTLE in 1 CARTON (69489-721-30) / 30 mL in 1 BOTTLE	07 Jun, 2019	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Exelderm

Sulconazole Nitrate

Cream
Journey Medical Corporation
NDC: 69489-711

Exelderm

Product Elements:

Exelderm sulconazole nitrate sulconazole nitrate sulconazole propylene glycol poloxamer 407 polysorbate 20 butylated hydroxyanisole water sodium hydroxide nitric acid

Indications and Usage:

Indications and usage exelderm (sulconazole nitrate, usp) 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 exelderm solution and clinical improvement usually occurs within one week.

General Precautions:

General exelderm (sulconazole nitrate, usp) solution, 1.0% is for external use only. avoid contact with the eyes. if irritation develops, the solution should be discontinued and appropriate therapy instituted.

Dosage and Administration:

Dosage and 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 exelderm (sulconazole nitrate) 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.

Contraindications:

Contraindications exelderm (sulconazole nitrate, usp) solution, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of the ingredients.

Adverse Reactions:

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.

Use in Pregnancy:

Pregnancy sulconazole nitrate has been shown to be embryotoxic in rats when given in doses 125 times the human dose (in mg/kg). the drug at this dose given orally to rats also resulted in prolonged gestation and dystocia. several females died during the perinatal period, most likely due to labor complications. sulconazole nitrate was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day. there are no adequate and well-controlled studies in pregnant women. sulconazole nitrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use:

Pediatric use safety and effectiveness in children have not been established.

Geriatric Use:

Geriatric use clinical studies of exelderm solution, 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.

Description:

Description exelderm (sulconazole nitrate, usp) solution, 1.0% is a broad-spectrum antifungal agent intended for topical application. sulconazole nitrate, usp, the active ingredient in exelderm solution, is an imidazole derivative with antifungal and antiyeast activity. its chemical name is (Â±)-1-[2,4-dichloro-Î²-[(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 130Â°c. exelderm 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

Clinical Pharmacology:

Clinical pharmacology sulconazole nitrate is an imidazole derivative that inhibits the growth of the common pathogenic dermatophytes including trichophyton rubrum, trichophyton mentagrophytes, epidermophyton floccosum, and microsporum canis. it also inhibits the organism responsible for tinea versicolor, malassezia furfur, and certain gram-positive bacteria. a maximization test with sulconazole nitrate solution showed no evidence of irritation or contact sensitization.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

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.

How Supplied:

How supplied exelderm (sulconazole nitrate, usp) 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 â ndc 69489-721-30 avoid excessive heat, above 40Â° c (104Â° f), and protect from light. to report suspected adverse reactions, contact the fda at 1-800-fda-1088 or www.fda.gov/medwatch. journey Â® medical corporation manufactured for: journey medical corp. scottsdale, az 85258 www.jmcderm.com 141112 revised march 2021

Information for Patients:

Information for patients patients should be told to use exelderm solution as directed by the physician, to use it externally only, and to avoid contact with the eyes.

Package Label Principal Display Panel:

Principal display panel â 30 ml bottle label ndc 69489-721-30 exelderm Â® (sulconazole nitrate, usp) solution, 1.0% 30 ml rx only for topical use only. not for ophthalmic use. journey medical corporation principal display panel â 30 ml carton label

Principal display panel â 30 ml bottle label exelderm Â®â ndc 69489-721-30 (sulconazole nitrate, usp) solution, 1.0% rx only for topical use only. not for ophthalmic use. 30 ml principal display panel â 30 ml bottle label

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.