MICONOSOL - miconazole nitrate lotion 
Med-Pharmex, Inc

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Miconosol Lotion 1% and Spray 1% (Miconazole Nitrate)

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: 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: 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 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: Miconosol (Miconazole Nitrate) Lotion in 60 mL containers.
Miconosol (Miconazole Nitrate) Spray in 120 mL and 240 mL containers.

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

August 1997


Miconosol Lotion 60mL Label

Miconosol Spray 120mL Label

Miconosol Spray 240mL Label

MICONOSOL 
miconazole nitrate lotion
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:54925-031
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate1.0 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54925-031-0660 mL in 1 BOTTLE
2NDC:54925-031-12120 mL in 1 BOTTLE, SPRAY
3NDC:54925-031-24240 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20019610/08/2012
Labeler - Med-Pharmex, Inc (025353699)

Revised: 10/2012
Document Id: dea9b590-c3d0-4cb9-8916-f754fa436f84
Set id: 51e05938-33c2-467f-ab4f-2d519896eb91
Version: 2
Effective Time: 20121008
 
Med-Pharmex, Inc