Micazole Lotion™ 1% & Micazole Spray™ 1%

Micazole by

Drug Labeling and Warnings

Micazole by is a Animal medication manufactured, distributed, or labeled by Henry Schein Animal Health, FIRST PRIORITY INCORPORATED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MICAZOLE- micaonazole spray 
Butler Animal health Supply, LLC dba Covetrus North America

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Micazole Lotion™ 1% & Micazole Spray™ 1%

(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.

Distributed by:
Henry Schein Animal Health
Dublin, OH 43017
www.henryscheinvet.com

ANADA #200-362, Approved by FDA

2 fl oz (60 mL)

4 fl oz (120 mL)

8 fl oz (240 mL)

MICAZOLE 
micaonazole spray

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-2201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	11.5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-2201-6	72 in 1 CASE
1		60 mL in 1 BOTTLE, DROPPER
2	NDC: 11695-2201-1	12 in 1 CASE
2		120 mL in 1 BOTTLE, SPRAY
3	NDC: 11695-2201-2	12 in 1 CASE
3		240 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200362	07/01/2013	09/30/2019

Labeler - Butler Animal health Supply, LLC dba Covetrus North America (603750329)

Establishment
Name	Address	ID/FEI	Business Operations
FIRST PRIORITY INCORPORATED		179925722	manufacture, label

Revised: 8/2019

Document Id: 93c04fa1-c884-4c6d-be75-c23e0acf0fe8

50578-4

Set id: dee55302-ba2d-44ef-8c6f-be77bc83f014

Version: 9

Effective Time: 20190820

 

Butler Animal health Supply, LLC dba Covetrus North America