Podiatrole

Ketoconazole 2% And Urea 20%

V2 Pharma, Llc
Human Prescription Drug
NDC 72835-302

Podiatrole also known as Ketoconazole 2% And Urea 20% is a human prescription drug labeled by 'V2 Pharma, Llc'. National Drug Code (NDC) number for Podiatrole is 72835-302. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Podiatrole drug includes . The currest status of Podiatrole drug is Active.

Drug Information:

Drug NDC:	72835-302
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:	Podiatrole
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:	Ketoconazole 2% And Urea 20%
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	V2 Pharma, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Kit
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:
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:
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:	UNAPPROVED DRUG OTHER
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:	06 Jan, 2023
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	16 Jun, 2026
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.
Listing Expiration Date:	31 Dec, 2024
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:
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
UNII:
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.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
72835-302-02	1 KIT in 1 CARTON (72835-302-02) * 1 TUBE in 1 BOX (GS1:3005361109455) / 85 g in 1 TUBE * 1 TUBE in 1 CARTON (51672-1298-2) / 30 g in 1 TUBE	06 Jan, 2023	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

Podiatrole

Ketoconazole 2% And Urea 20%

Kit
V2 Pharma, LLC
NDC: 72835-302

Purpose:

Purpose keratolytic

Product Elements:

Podiatrole ketoconazole 2% and urea 20% ketoconazole ketoconazole ketoconazole ketoconazole butylated hydroxyanisole cetyl alcohol isopropyl myristate polysorbate 60 polysorbate 80 propylene glycol water sorbitan monostearate stearyl alcohol white to off-white urea urea urea urea water stearic acid propylene glycol isopropyl myristate isopropyl palmitate sodium laureth sulfate sodium hydroxide xanthan gum carbomer homopolymer, unspecified type phenoxyethanol

Indications and Usage:

Indication and usage for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by trichophyton rubrum, t. mentagrophytes and epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by malassezia furfur (pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by candida spp. and in the treatment of seborrheic dermatitis. keratolytic.

Indications and usage ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by trichophyton rubrum, t. mentagrophytes and epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by malassezia furfur (pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by candida spp. and in the treatment of seborrheic dermatitis.

Warnings:

Warnings for external use only. avoid contact with eyes, lips or mucous membranes. do not use on areas of broken skin.

Warnings ketoconazole cream, 2% is not for ophthalmic use.

Warnings for external use only. avoid contact with eyes, lips or mucous membranes. do not use on areas of broken skin. do not use if known hypersensitivity to any of the listed ingredients. precautions stop use and ask a doctor if redness or irritation develops. keep this and all other medications out of reach of children. if swallowed, get medical help or contact a poison control center right away. pregnancy if pregnant or breast feeding, ask a health professional before use.

Do Not Use:

Warnings for external use only. avoid contact with eyes, lips or mucous membranes. do not use on areas of broken skin.

Warnings ketoconazole cream, 2% is not for ophthalmic use.

General Precautions:

General if a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. hepatitis (1:10,000 reported incidence) and, at high doses, lowered testosterone and acth induced corticosteroid serum levels have been seen with orally administered ketoconazole; these effects have not been seen with topical ketoconazole.

Dosage and Administration:

Dosage and administration first apply ketoconazole cream, 2% to cover the affected and immediate surrounding area. then apply urea 20% cream and rub into skin until completely absorbed. apply twice a day or as directed by your physician.

Dosage and administration cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor it is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. patients with tinea versicolor usually require two weeks of treatment. patients with tinea pedis require six weeks of treatment. seborrheic dermatitis ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until clinical clearing. if a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.

Directions apply to the affected areas twice a day or as directed by a physician. rub into the skin until completely absorbed.

Stop Use:

Precautions stop use and ask a doctor if redness or irritation develops. keep this and all other medications out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Contraindications:

Contraindications do not use if known hypersensitivity to any of the listed ingredients of any of the components included on the kit.

Contraindications ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

Adverse Reactions:

Adverse reactions during clinical trials 45 (5.0%) of 905 patients treated with ketoconazole cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. one of the patients treated with ketoconazole cream developed a painful allergic reaction. in worldwide postmarketing experience, rare reports of contact dermatitis have been associated with ketoconazole cream or one of its excipients, namely propylene glycol.

Use in Pregnancy:

Pregnancy if pregnant or breast feeding, ask a health professional before use.

Pregnancy teratogenic effects pregnancy category c ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day, (10 times the maximum recommended human oral dose). however, these effects may be related to maternal toxicity, which was seen at this and higher dose levels. there are no adequate and well-controlled studies in pregnant women. ketoconazole 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.

Description:

Podiatrole description podiatrole is supplied as 3 components in a kit : -2 tubes of ketoconazole cream 2%, 30g (60g total in kit) (ndc 51672-1298-2), urea 20% cream, 85g

Description ketoconazole cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of butylated hydroxyanisole (bha), cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol. ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl] piperazine and has the following structural formula: molecular formula: c26h28cl2n4o4 molecular weight: 531.43 chemical structure

Clinical Pharmacology:

Clinical pharmacology when ketoconazole cream, 2% was applied dermally to intact or abraded skin of beagle dogs for 28 consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method having a lower detection limit of 2 ng/ml. after a single topical application to the chest, back and arms of normal volunteers, systemic absorption of ketoconazole was not detected at the 5 ng/ml level in blood over a 72-hour period. two dermal irritancy studies, a human sensitization test, a phototoxicity study and a photoallergy study conducted in 38 male and 62 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity and no photoallergenic potential due to ketoconazole cream, 2%. microbiology ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the in vitro growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: trichophy Read more...

ton rubrum, t. mentagrophytes, t. tonsurans, microsporum canis, m. audouini, m. gypseum and epidermophyton floccosum; yeasts: candida albicans, malassezia ovale (pityrosporum ovale) and c. tropicalis; and the organism responsible for tinea versicolor, malassezia furfur (pityrosporum orbiculare). only those organisms listed in the indications and usage section have been proven to be clinically affected. development of resistance to ketoconazole has not been reported. mode of action in vitro studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. it is postulated that the therapeutic effect of ketoconazole in seborrheic dermatitis is due to the reduction of m. ovale, but this has not been proven.

Mechanism of Action:

Mode of action in vitro studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. it is postulated that the therapeutic effect of ketoconazole in seborrheic dermatitis is due to the reduction of m. ovale, but this has not been proven.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility a long-term feeding study in swiss albino mice and in wistar rats showed no evidence of oncogenic activity. the dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development. the ames' salmonella microsomal activator assay was also negative.

How Supplied:

Store at 20Â°-25Â°c (68Â° to 77Â°f); keep away from heat and flame. protect from freezing. [see usp controlled room temperature.]

Ketoconazole cream, 2% is supplied in 30 g (ndc 51672-1298-2) tubes. storage store at room temperature 15Â° to 25Â°c (59Â° to 77Â°f); avoid freezing and excessive heat above 40Â°c (104Â°f).

Package Label Principal Display Panel:

Principal display panel - kit carton v2 pharma, llc podiatrole ndc 72835-302-03 rx only principal display panel - kit carton

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.