Econazole Nitrate by Physicians Total Care, Inc. ECONAZOLE NITRATE cream

Econazole Nitrate by

Drug Labeling and Warnings

Econazole Nitrate by is a Prescription medication manufactured, distributed, or labeled by Physicians Total Care, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx only

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIC USE

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: 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.

• Dermatophytes: Yeasts
• Epidermophyton floccosum: Candida albicans
• Microsporum audouini: Malassezia furfur

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

• Dermatophytes: Yeasts
• Trichophyton verrucosum: Candida guillermondii

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.

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, and 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: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: 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 tube

Store Econazole Nitrate 1% Cream below 86°F (30°C).

E. FOUGERA & CO.
A division of Nycomed US Inc.
MELVILLE, NEW YORK 11747

I2312A
R12/07
#20

Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK      74146

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 GRAM CARTON

ECONAZOLE NITRATE

CREAM, 1%

Rx only

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIC USE

WARNING: Keep out of

reach of children.

NET WT 30 grams

INGREDIENTS AND APPEARANCE

ECONAZOLE NITRATE 
econazole nitrate cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 54868-5042(NDC:0168-0312)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECONAZOLE NITRATE (UNII: H438WYN10E) (ECONAZOLE - UNII:6Z1Y2V4A7M)	ECONAZOLE NITRATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54868-5042-0	1 in 1 CARTON
1		30 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076075	05/19/2004

Labeler - Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Business Operations
Physicians Total Care, Inc.		194123980	relabel