MICONOSOL- miconazole nitrate lotion

Miconosol by

Drug Labeling and Warnings

Miconosol by is a Animal medication manufactured, distributed, or labeled by Med-Pharmex, Inc, Med-Pharmex, Inc., Erregierre. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

ANADA  #200-196, approved by FDA.

DESCRIPTION: Miconosol (Miconazole Nitrate) Lotion and 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: Miconosol (Miconazole Nitrate) Lotion and 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 Miconosol (Miconazole Nitrate) Lotion and 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.

Lotion: Apply a light covering of Miconosol (Miconazole Nitrate) Lotion to affected areas, once daily, for 2 to 4 weeks. Application is best accomplished using a gauze pad or cotton swab. 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.

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: Miconosol (Miconazole Nitrate) Lotion in 60 mL containers.
Miconosol (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

MICONOSOL 
miconazole nitrate lotion

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 54925-031
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: 54925-031-06	60 mL in 1 BOTTLE
2	NDC: 54925-031-12	120 mL in 1 BOTTLE, SPRAY
3	NDC: 54925-031-24	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 - Med-Pharmex, Inc (025353699)