PRICONAZOLE- miconazole nitrate spray 
FIRST PRIORITY INCORPORATED

----------

Priconazole® Lotion, 1% & Spray, 1%


(miconazole nitrate)

Topical antifungal agent for dogs and cats.

DESCRIPTION:

Priconazole® 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:

Priconazole® 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 Priconazole® Lotion, 1% or 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 Priconazole® 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:

Priconazole® Lotion, 1% (miconazole nitrate) is available in 30 mL & 60 mL bottles with droppers, and Priconazole® 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.

Rev. 08-08

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

www.prioritycare.com

ANADA# 200-362, Approved by FDA

Priority Care and Priconazole are registered trademarks of First Priority, Inc.

image of 60 mL bottle/case label

image of 60 mL bottle/case label

image of 120 mL bottle/case label

image of 120 mL bottle/case label

image of 240 mL bottle/case label

image of 240 mL bottle/case label

PRICONAZOLE 
miconazole spray
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:58829-297
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE11.5 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58829-297-6072 in 1 CASE
160 mL in 1 BOTTLE, DROPPER
2NDC:58829-297-1212 in 1 CASE
2120 mL in 1 BOTTLE, SPRAY
3NDC:58829-297-2412 in 1 CASE
3240 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20036208/15/2008
Labeler - FIRST PRIORITY INCORPORATED (179925722)
Establishment
NameAddressID/FEIBusiness Operations
FIRST PRIORITY INCORPORATED179925722manufacture

Revised: 4/2013
Document Id: 45cd1f2b-2dd2-4312-a199-7112bfcb3e1f
Set id: 0a537bd5-0a8b-4cc7-a5d3-53aa47f0c860
Version: 4
Effective Time: 20130405
 
FIRST PRIORITY INCORPORATED