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 July 17, 2023

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    (miconazole nitrate)

    Approved by FDA under ANADA # 200-196

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

    DESCRIPTION: Miconosol Lotion 1% and Miconosol Spray 1% are synthetic antifungal agents for use in dogs and cats. Both Miconosol Lotion 1% and Miconosol Spray 1% contain 1.15% miconazole nitrate (equivalent to 1% miconazole base by weight), polyethylene glycol 400 and ethyl alcohol 55%.

  • INDICATIONS:

    Miconosol Lotion 1% and Miconosol Spay 1% are 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 Lotion 1% or Miconosol Spray 1%, 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.

    Miconosol Lotion 1%: 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.

    Miconosol Spray 1%: 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.

  • SPL UNCLASSIFIED SECTION

    CONTACT INFORMATION:
    To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Med-Pharmex at (800) 587-4306.

    For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae

  • HOW SUPPLIED

    HOW SUPPLIED:

    Miconosol Lotion 1% is available in 60 mL containers.

    Miconosol Spray 1% is available in 120 mL and 240 mL spray bottles.


    Manufactured by:
    Med-Pharmex, Inc.
    Pomona, CA 91767

    Rev. July 2023

  • PRINCIPAL DISPLAY PANEL

    MPX Miconosol Lotion - 60 mL - Label

    MPX Miconosol Spray - 120 mL - Label

    MPX Miconosol Spray - 240 mL - Label

  • INGREDIENTS AND APPEARANCE
    MICONOSOL 
    miconazole nitrate lotion
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54925-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate1.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 1 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)
    Registrant - Med-Pharmex, Inc. (025353699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Med-Pharmex, Inc.025353699manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Erregierre437721244api manufacture