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Micazole

Butler Schein Animal Health

Micazole Lotion 1% & Micazole Spray 1%


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

(miconazole nitrate)

Topical antifungal agent for dogs and cats.

DESCRIPTION:

Micazole Lotion 1% & Micazole Spray 1% (miconazole nitrate) is a synthetic antifungal agent for use in dogs and cats. It contains: 1.15% miconazole nitrate (equivalent to 1% miconazole base by weight), polyethylene glycol 400, and ethyl alcohol 55%.

INDICATIONS:

Micazole Lotion 1% & Micazole Spray 1% (miconazole nitrate) is indicated for the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

PRECAUTIONS:

In the event of sensitization or irritation due to Micazole Lotion 1% or Micazole Spray 1% (miconazole nitrate), treatment should be discontinued. Avoid contact with eyes, since irritation may result. Wash hands thoroughly after administration to avoid spread of fungal infection.

DOSAGE AND ADMINISTRATION:

Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide, or by culture on an appropriate medium.

Lotion: Apply a light covering of Micazole Lotion 1% (miconazole nitrate) to affected areas, once daily, for 2 to 4 weeks. Application is best accomplished using a gauze pad or cotton swab.

Spray: Spray affected areas from a distance of 2 to 4 inches to apply a light covering, once daily for 2 to 4 weeks. Do not allow pet to contact finished wood surfaces until pet is thoroughly dried.

Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. If no improvement is noticed within 2 weeks, diagnosis should be re-evaluated. Difficult cases may require treatment for 6 weeks. General measures in regard to hygiene should be observed to control sources of infection or reinfection. Clipping of hair around and over the sites of infection should be done at the start of treatment and again as necessary.

HOW SUPPLIED:

Micazole Lotion 1% (miconazole nitrate) is available in 60 mL bottles with droppers, and Micazole Spray 1% (miconazole nitrate) is available in 120 mL & 240 mL bottles with spray misters.

CAUTION:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Iss. 04-09

Distributed Exclusively by

Henry Schein Animal Health

Dublin, OH 43017

www.henryscheinvet.com

Manufactured by:

First Priority, Inc. Elgin, IL U.S.A.

www.prioritycare.com

ANADA# 200-362, Approved by FDA

Micazole

image of 60 mL bottle label

Micazole

image of 120 mL bottle label

Micazole

image of 240 mL bottle label

Micazole

Micaonazole SPRAY

Product Information

Product Type Prescription animal drug label Item Code (Source) NDC:11695-2201
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE MICONAZOLE 11.5 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE, DROPPER
2 120 in 1 BOTTLE, SPRAY
3 240 in 1 BOTTLE, SPRAY
4 NDC:11695-2201-2 12 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200362 2013-07-01


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