Label: ECONAVIX- econazole nitrate kit

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 23, 2020

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  • SPL UNCLASSIFIED SECTION

    Rx Only

    For Topical Use Only

  • 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:

    Chemical Structure
  • 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.

    DermatophytesYeasts
    Epidermophyton floccosumCandida albicans
    Microsporum audouiniMalassezia furfur
    Microsporum canis
    Microsporum gypseum
    Trichophyton mentagrophytes
    Trichophyton rubrum
    Trichophyton tonsurans

    Econazole nitrate exhibits broad-spectrum antifungal activity against the following organisms in vitro, but the clinical significance of these data is unknown.

    DermatophytesYeasts
    Trichophyton verrucosumCandida guillermondii
    Candida parapsilosis
    Candida 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.

  • 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.

    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)

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

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Teligent Pharma, Inc.
    Buena, New Jersey 08310

    PI-022-00
    Rev 01/2019

  • PRINCIPAL DISPLAY PANEL

    Rx Only

    FOR TOPICAL USE ONLY

    NOT FOR OPHTHALMIC USE

    label

  • INGREDIENTS AND APPEARANCE
    ECONAVIX 
    econazole nitrate kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72275-735
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72275-735-771 in 1 CARTON; Type 1: Convenience Kit of Co-Package12/20/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 TUBE 1 g
    Part 20 TUBE 1 g
    Part 30 TUBE 1 g
    Part 1 of 3
    ECONAZOLE NITRATE 
    econazole nitrate cream
    Product Information
    Item Code (Source)NDC:52565-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECONAZOLE NITRATE (UNII: H438WYN10E) (ECONAZOLE - UNII:6Z1Y2V4A7M) ECONAZOLE NITRATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07657408/01/2013
    Part 2 of 3
    ECONAZOLE NITRATE 
    econazole nitrate cream
    Product Information
    Item Code (Source)NDC:52565-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECONAZOLE NITRATE (UNII: H438WYN10E) (ECONAZOLE - UNII:6Z1Y2V4A7M) ECONAZOLE NITRATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07657408/01/2013
    Part 3 of 3
    ECONAZOLE NITRATE 
    econazole nitrate cream
    Product Information
    Item Code (Source)NDC:52565-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECONAZOLE NITRATE (UNII: H438WYN10E) (ECONAZOLE - UNII:6Z1Y2V4A7M) ECONAZOLE NITRATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07657408/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07657412/20/2020
    Labeler - Primary Pharmaceuticals, Inc. (066126126)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teligent Pharma, Inc.011036910manufacture(52565-022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rainbow Gold800695152repack(72275-735)