NDC 45802-466 Econazole Nitrate

Econazole Nitrate

NDC Product Code 45802-466

NDC CODE: 45802-466

Proprietary Name: Econazole 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: Econazole 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.

  • Econazole is used to treat a variety of fungal skin infections such as athlete's foot, 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. Econazole is an azole antifungal that works by preventing the growth of fungus.

NDC Code Structure

NDC 45802-466-11

Package Description: 1 TUBE in 1 CARTON > 30 g in 1 TUBE

NDC 45802-466-35

Package Description: 1 TUBE in 1 CARTON > 15 g in 1 TUBE

NDC 45802-466-53

Package Description: 1 TUBE in 1 CARTON > 85 g in 1 TUBE

NDC Product Information

Econazole Nitrate with NDC 45802-466 is a a human prescription drug product labeled by Perrigo New York Inc. The generic name of Econazole Nitrate is econazole nitrate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Perrigo New York Inc

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.

Econazole 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.

  • ECONAZOLE 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.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • WATER (UNII: 059QF0KO0R)
  • PEG-5 OLEATE (UNII: 0240V77G50)
  • PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)

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.

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: Perrigo New York Inc
Labeler Code: 45802
FDA Application Number: ANDA076479 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: ANDA - A product marketed under an approved Abbreviated 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: 08-08-2006 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’.

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Information for Patients

Econazole Topical

Econazole Topical is pronounced as (e kon' na zole)

Why is econazole topical medication prescribed?
Econazole is used to treat skin infections such as athlete's foot, jock itch, and ringworm.This medication is sometimes prescribed for other uses; ask your doctor or phar...
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Econazole 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

For Topical Use OnlyNot for Ophthalmic UseRx Only

Description

Econazole Nitrate Cream, 1% contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol-7 stearate, and purified water. The white to off-white soft cream is for topical use only.Chemically, econazole nitrate is 1-[2-{(4-chlorophenyl)methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows:

Clinical Pharmacology

After topical application to the skin of normal subjects, systemic absorption of econazole nitrate is extremely low. Although most of the applied drug remains on the skin surface, drug concentrations were found in the stratum corneum which, by far, exceeded the minimum inhibitory concentration for dermatophytes. Inhibitory concentrations were achieved in the epidermis and as deep as the middle region of the dermis. Less than 1% of the applied dose was recovered in the urine and feces.

Microbiology -

Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.DermatophytesYeastsEpidermophyton floccosumTrichophyton mentagrophytesCandida albicansMicrosporum audouiniTrichophyton rubrumMalassezia furfurMicrosporum canisTrichophyton tonsuransMicrosporum gypseumEconazole nitrate exhibits broad-spectrum antifungal activity against the following organisms in vitro, but the clinical significance of these data is unknown.DermatophytesYeastsTrichophyton verrucosumCandida guillermondiiCandida parapsilosisCandida tropicalis

Indications And Usage

Econazole Nitrate Cream, 1% is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

Contraindications

Econazole Nitrate Cream, 1% is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

Warnings

Econazole Nitrate Cream, 1% is not for ophthalmic use.

General -

If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. For external use only. Avoid introduction of Econazole Nitrate Cream, 1% into the eyes.

Carcinogenesis, Mutagenesis, Impairment Of Fertility -

Long-term animal studies to determine carcinogenic potential have not been performed.

Fertility (Reproduction) -

Oral administration of econazole nitrate in rats has been reported to produce prolonged gestation. Intravaginal administration in humans has not shown prolonged gestation or other adverse reproductive effects attributable to econazole nitrate therapy.

Pregnancy Category C -

Econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. Fetotoxic or embryotoxic effects were observed in Segment I oral studies with rats receiving 10 to 40 times the human dermal dose. Similar effects were observed in Segment II or Segment III studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose. Econazole nitrate should be used in the first trimester of pregnancy only when the physician considers it essential to the welfare of the patient. The drug should be used during the second and third trimesters of pregnancy only if clearly needed.

Nursing Mothers -

It is not known whether econazole nitrate is excreted in human milk. Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. Also, in lactating rats receiving large oral doses (40 or 80 times the human dermal dose), there was a reduction in post partum viability of pups and survival to weaning; however, at these high doses, maternal toxicity was present and may have been a contributing factor. Caution should be exercised when econazole nitrate is administered to a nursing woman.

Adverse Reactions

During clinical trials, approximately 3% of patients treated with econazole nitrate 1% cream reported side effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging, and erythema. One case of pruritic rash has also been reported.

Overdosage

Overdosage of econazole nitrate in humans has not been reported to date. In mice, rats, guinea pigs and dogs, the oral LD 50 values were found to be 462, 668, 272, and >160 mg/kg, respectively.

Dosage And Administration

Sufficient Econazole Nitrate Cream, 1% should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis.Early relief of symptoms is experienced by the majority of patients and 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 and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

How Supplied

Econazole Nitrate Cream, 1% is available as follows:15 g tube (NDC 45802-466-35)30 g tube (NDC 45802-466-11)85 g tube (NDC 45802-466-53)

Storage

Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature].Manufactured By PerrigoBronx, NY 10457Distributed By PerrigoAllegan, MI 49010 • www.perrigo.comRev. 05-15: 2F300 RC JX1

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