Label: MICONOSOL - miconazole nitrate lotion
- NDC Code(s): 54925-031-06, 54925-031-12, 54925-031-24
- Packager: Med-Pharmex, Inc
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated October 8, 2012
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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%.Close
- 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.Close
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.Close
- 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.Close
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.Close
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.Close
- INGREDIENTS AND APPEARANCE
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)