Exelderm

Sulconazole Nitrate

Journey Medical Corporation
Human Prescription Drug
NDC 69489-711

Exelderm also known as Sulconazole Nitrate is a human prescription drug labeled by 'Journey Medical Corporation'. National Drug Code (NDC) number for Exelderm is 69489-711. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Exelderm drug includes Sulconazole Nitrate - 10 mg/g . The currest status of Exelderm drug is Active.

Drug Information:

Drug NDC:	69489-711
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:	Cream
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/g
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:	NDA018737
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:	106366 208117
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
69489-711-60	1 TUBE in 1 CARTON (69489-711-60) / 60 g in 1 TUBE	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 stearyl alcohol isopropyl myristate cetyl alcohol polysorbate 60 sorbitan monostearate glyceryl monostearate peg-100 stearate ascorbyl palmitate water sodium hydroxide nitric acid

Indications and Usage:

Indications and usage exelderm (sulconazole nitrate, usp) 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. *efficacy for this organism in the organ system was studied in fewer than ten infections.

General 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.

Dosage and 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 exelderm (sulconazole nitrate, usp) 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.

Use in Pregnancy:

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.

Pediatric Use:

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

Geriatric Use:

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.

Description:

Description exelderm (sulconazole nitrate, usp) cream, 1.0% is a 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 (Â±)-1-[2,4-dichloro- Î² -[( p -chlorobenzyl)-thiol]-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 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

Clinical Pharmacology:

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 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.

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.

Clinical Studies:

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.

How Supplied:

How supplied exelderm (sulconazole nitrate, usp) 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 â ndc 69489-711-60 avoid excessive heat, above 40Â° c (104Â° f). 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 141113 revised march 2021

Information for Patients:

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.

Package Label Principal Display Panel:

Principal display panel â 60 g carton label exelderm Â® (sulconazole nitrate, usp) cream, 1.0% ndc 69489-711-60 net wt. 60 g journey medical corporation 60 gram carton label

Principal display panel â 60 gram tube label exelderm Â® (sulconazole nitrate, usp) cream, 1.0% avoid excessive heat, above 40Â°c (104Â° f). ndc 69489-711-60 rx only net wt. 60 g for topical use only. not for ophthalmic use. 60 gram tube 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.