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MicaVed

VEDCO

MicaVed Spray 1% (Miconazole Nitrate)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION


(miconazole nitrate)

Topical antifungal agent for dogs and cats.

DESCRIPTION:

Miconazole Nitrate Lotion, 1% & 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:

Miconazole Nitrate Lotion, 1% & 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 Miconazole Nitrate Lotion, 1% & 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 Miconazole Nitrate 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:

Miconazole Nitrate Lotion, 1% (miconazole nitrate) is available in 30 mL & 60 mL bottles with droppers, and Miconazole Nitrate 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

ANADA# 200-362, Approved by FDA

Manufactured by: First Priority, Inc.  Elgin, IL U.S.A.

www.prioritycare.com

MicaVed

image of 120 mL bottle/case label (front)

MicaVed

image of 120 mL bottle label (middle of onsert)

MicaVed

image of 120 mL bottle label (back of onsert)

MicaVed

image of 240 mL bottle/case label (front of onsert)

MicaVed

image of 240 mL bottle label (middle of onsert)

MicaVed

image of 240 mL bottle label (back of onsert)

MicaVed

Miconazole SPRAY

Product Information

Product Type Prescription animal drug label Item Code (Source) NDC:50989-516
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
1 120 in 1 BOTTLE, SPRAY
2 240 in 1 BOTTLE, SPRAY
3 NDC:50989-516-74 12 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200362 2012-06-30


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