NDC 54868-5042 Econazole Nitrate

NDC Product Code 54868-5042

NDC 54868-5042-0

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Econazole Nitrate with NDC 54868-5042 is a product labeled by Physicians Total Care, Inc.. The generic name of Econazole Nitrate is . The product's dosage form is and is administered via form.

Labeler Name: Physicians Total Care, Inc.

Dosage Form: -

Product Type: 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.

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.

  • MINERAL OIL (UNII: T5L8T28FGP)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: Physicians Total Care, Inc.
Labeler Code: 54868
Start Marketing Date: 05-19-2004 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: 12-31-2017 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: I 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 Label Images

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

Rx onlyFOR TOPICAL USE ONLYNOT FOR OPHTHALMIC USE

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.

Description

Econazole Nitrate Cream, 1% contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of pegoxyl 7 stearate, peglicol 5 oleate, mineral oil, benzoic acid, butylated hydroxyanisole, and purified water. The white to off-white soft cream is for topical use only.Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl)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

Microbiology: Econazole nitrate has been shown to be active against most strains of the following microorganisms, bothin vitro and in clinical infections as described in theINDICATIONS AND USAGE section.DermatophytesYeastsEpidermophyton floccosumCandida albicansMicrosporum audouiniMalassezia furfurMicrosporum canisMicrosporum gypseumTrichophyton mentagrophytesTrichophyton rubrumTrichophyton tonsuransEconazole nitrate exhibits broad-spectrum antifungal activity against the following organismsin 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 byTrichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, andEpidermophyton 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 Precautions

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 into the eyes.

Carcinogenesis & Mutagenesis & Impairment Of Fertility

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies to determine carcinogenic potential have not been performed.

Pregnancy

Pregnancy:Teratogenic effects-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

Nursing Mothers: It is not know 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 supplied as follows:NDC 54868-5042-0 30 gram tubeStore Econazole Nitrate 1% Cream below 86°F (30°C).E. FOUGERA & CO.A division of Nycomed US Inc.MELVILLE, NEW YORK
11747I2312A R12/07 #20Relabeling of "Additional Barcode Label" by:Physicians Total Care, Inc.Tulsa, OK      74146

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