Drugplain

Econazole Nitrate 10 mg/g

Econazole Nitrate · CREAM · Preferred Pharmaceuticals Inc.

3 Recalls on Record
Plain English

Econazole Nitrate is a cream containing econazole nitrate at 10 mg/g, taken topical. Manufactured by Preferred Pharmaceuticals Inc..

Key Facts

Brand Name
Econazole Nitrate
Generic Name
Econazole Nitrate
NDC Code (Product)
68788-8884
Manufacturer
Preferred Pharmaceuticals Inc.
Strength
10 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA076479
Marketing Start
08/08/2006

Recall History

3 Recalls on Record
Class II03/24/2022

Preferred Pharmaceuticals, Inc.

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated
Class II07/19/2021

Teligent Pharma, Inc.

Correct Labeled Product Mispack

TerminatedVoluntary: Firm initiated
Class II03/15/2022

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue59 reports
drug ineffective56 reports
dyspnoea47 reports
pain45 reports
nausea44 reports
rash44 reports
diarrhoea42 reports
dizziness41 reports
asthenia38 reports
headache38 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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.

Dosage & Administration

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.

Warnings

WARNINGS Econazole Nitrate Cream is not for ophthalmic use.

Contraindications

CONTRAINDICATIONS Econazole Nitrate Cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

Drug Interactions

Drug Interactions Warfarin Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulation effect. Most cases reported product application with use under occlusion, genital application, or application to large body surface area which may increase the systemic absorption of econazole nitrate. Monitoring of International Normalized Ratio (INR) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.

Adverse Reactions

ADVERSE REACTIONS During clinical trials, approximately 3% of patients treated with econazole nitrate cream, 1% 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.

Frequently Asked Questions

What is Econazole Nitrate used for?

Econazole Nitrate contains Econazole Nitrate. It is a cream taken topical. Consult your doctor for specific uses.

Is Econazole Nitrate a controlled substance?

Econazole Nitrate is not classified as a controlled substance by the DEA.

What is the generic name for Econazole Nitrate?

The generic name for Econazole Nitrate is Econazole Nitrate. There are 2 other brand versions of Econazole Nitrate.

What is the NDC code for Econazole Nitrate 10 mg/g?

The NDC (National Drug Code) for Econazole Nitrate 10 mg/g is 68788-8884, listed by Preferred Pharmaceuticals Inc..

Product NDC

68788-8884

Package NDC

68788-8884-3

Other Econazole Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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