NDC 70512-029 Econazole Nitrate

Econazole Nitrate

NDC Product Code 70512-029

NDC Code: 70512-029

Proprietary Name: Econazole Nitrate Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 70512 - Kbs Solutions
    • 70512-029 - Econazole Nitrate

NDC 70512-029-30

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

NDC 70512-029-85

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

NDC Product Information

Econazole Nitrate with NDC 70512-029 is a a human prescription drug product labeled by Kbs Solutions. The generic name of Econazole Nitrate is econazole nitrate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Kbs Solutions

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 Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipAbout 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.

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

Administration Route(s)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Kbs Solutions
Labeler Code: 70512
FDA Application Number: ANDA076574 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-04-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

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

Description

Econazole Nitrate Cream 1% 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.

Indication 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.

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 1% into the eyes.
Carcinogenicity Studies
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.
PregnancyPregnancy 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.

Overdose

Overdosage of econazole nitrate in humans has not been reported to date. In mice, rats, guinea pigs and

dogs, the oral LD values were found to be 462, 668, 272, and >160 mg/kg, respectively.

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.

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 tubes of 15 grams (NDC 52565-022-15), 30

grams (NDC 52565-022-30), and 85 grams (NDC 52565-022-85).

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

Teligent Pharma, Inc.

Buena, New Jersey 08310

Rev. 01/2016

* Please review the disclaimer below.

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