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

Drug Label Information

Updated 10/12

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  • 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%.

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  • 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.

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  • 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.

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  • 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.

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  • HOW SUPPLIED

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

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  • PRECAUTIONS

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

    August 1997

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  • INGREDIENTS AND APPEARANCE
    MICONOSOL 
    miconazole nitrate lotion
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:54925-031
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Miconazole Nitrate (Miconazole) 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)
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