MICAZOLE- miconazole nitrate spray

Micazole by

Drug Labeling and Warnings

Micazole by is a Animal medication manufactured, distributed, or labeled by Henry Schein Animal Health, Med-Pharmex, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

ANADA  #200-196, approved by FDA.

DESCRIPTION: Miconazole Nitrate Spray 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 & USAGE

INDICATIONS: Miconazole Nitrate Spray is indicated for the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes.

PRECAUTIONS

PRECAUTIONS: In the event of sensitization or irritation due to Miconazole Nitrate Spray, treatment should be discontinued. Avoid contact with eyes, since irritation may result. Wash hands thoroughly after administration to avoid spread of fungal infection.

DOSAGE & ADMINISTRATION

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.

Spray: Spray affected areas from a distance of 2 to 4 inches to apply a light covering, once daily for 2 to 4 weeks. 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

HOW SUPPLIED: Miconazole Nitrate Spray in 120 mL and 240 mL containers.

PRECAUTIONS

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

August 1997

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MICAZOLE 
miconazole nitrate spray

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-4834
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M)	Miconazole Nitrate	1.0 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-4834-2	120 mL in 1 BOTTLE, SPRAY
2	NDC: 11695-4834-4	240 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200196	10/08/2012

Labeler - Henry Schein Animal Health (017880659)

Registrant - Med-Pharmex, Inc (025353699)

Establishment
Name	Address	ID/FEI	Business Operations
Med-Pharmex, Inc		025353699	manufacture