MICONAZOLE NITRATE 1%- micaonazole spray

Miconazole nitrate by

Drug Labeling and Warnings

Miconazole nitrate by is a Animal medication manufactured, distributed, or labeled by Butler Animal health Supply, LLC dba Covetrus North America, FIRST PRIORITY INCORPORATED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

Lotion/Spray
Topical Antifungal Agent For Dogs and Cats

PRECAUTIONS

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

For animal use only
Keep out of reach of children

Description:

Miconazole nitrate 1% Lotion/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:

Miconazole nitrate 1% Lotion/Spray 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 1% Lotion/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 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 1% Lotion 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.

Storage:

Store at controlled room temperature between 15º to 30ºC (59º-86ºF). Keep container tightly closed when not in use.

How supplied:

Miconazole nitrate 1% Lotion is available in 60 mL bottles with droppers. 

Miconazole nitrate 1% Spray is available in 120 mL and 240 mL bottles with spray misters.

Caution:

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

Reorder #014676 (60 mL), 0104677 (120 mL) and 014678 (240 mL)
Questions? (855) 724-3461

Distributed by:
Covetrus North America
400 Metro Place North
Dublin, OH 43017
covetrus.com

ANADA #200-362, Approved by FDA

60 mL:

AH-014676-02
REV: 0919

120 mL:

AH-014677-02
REV: 1019

240 mL:

AH-014678-02
REV: 1019

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE  1%
micaonazole spray

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-2221
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: 11695-2221-2	72 in 1 CASE
1		60 mL in 1 BOTTLE, DROPPER
2	NDC: 11695-2221-4	12 in 1 CASE
2		120 mL in 1 BOTTLE, SPRAY
3	NDC: 11695-2221-8	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	10/01/2019

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

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