NDC 72275-735 Econavix

Econazole Nitrate

NDC Product Code 72275-735

NDC 72275-735-77

Package Description: 1 KIT in 1 CARTON * 30 g in 1 TUBE * 30 g in 1 TUBE * 30 g in 1 TUBE

NDC Product Information

Econavix with NDC 72275-735 is a a human prescription drug product labeled by Primary Pharmaceuticals, Inc.. The generic name of Econavix is econazole nitrate. The product's dosage form is kit and is administered via topical form.

Labeler Name: Primary Pharmaceuticals, Inc.

Dosage Form: Kit - A packaged collection of related material.

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.

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

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.

Product Labeler Information

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

Labeler Name: Primary Pharmaceuticals, Inc.
Labeler Code: 72275
FDA Application Number: ANDA076574 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: 12-20-2020 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’.

* Please review the disclaimer below.

Econavix 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 Only

Manufactured by:Teligent Pharma, Inc.


Buena, New Jersey 08310


PI-022-00


Rev 01/2019

Description

Econazole Nitrate Cream contains the antifungal agent, econazole nitrate 1% in a water miscible base consisting of pegoxol 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

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 floccosumCandida albicansMicrosporum audouiniMalassezia furfurMicrosporum canisMicrosporum gypseumTrichophyton mentagrophytesTrichophyton rubrumTrichophyton tonsuransEconazole 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 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 is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

Warnings

Econazole Nitrate Cream 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 into the eyes.

Carcinogenicity Studies

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


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.

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

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 time 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 time 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.To report


SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdose

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 in the following:

30 gram tubes (NDC 52565-022-30)

Storage And Handling

Store at controlled room temperature 20° - 25°C (68° - 77°F).

* Please review the disclaimer below.