Label: MICONAZOLE NITRATE 1%- micaonazole spray

  • NDC Code(s): 11695-2221-2, 11695-2221-4, 11695-2221-8
  • Packager: Butler Animal health Supply, LLC dba Covetrus North America
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated March 11, 2024

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  • VETERINARY INDICATIONS

    Lotion/Spray
    Topical antifungal agent for dogs and cats

  • PRECAUTIONS

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

    Not for Use in Humans
    Keep Out of Reach of Children

    Approved by FDA under ANADA # 200-362

  • HOW SUPPLIED

    Miconazole nitrate 1% Lotion is available in 60 mL bottles with droppers.

    Miconazole nitrate 1% Spray is available in 120 mL and 240 mL bottles with spray mister.

  • Indications:

    For the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

  • Dosage:

    Apply a light covering to affected areas, once daily for 2 to 4 weeks. See accompanying literature for full directions.
    Avoid contact with eyes, since irritation may result.
    Wash hands thoroughly after administration to avoid spread of fungal infection.

  • INFORMATION FOR OWNERS/CAREGIVERS

    image of eye clock

    Lot No. / Exp. Date

  • Active ingredient:

    Miconazole nitrate . . . . . . . . . . . . . . . . . 1.15%
    (equivalent to 1% miconazole base by weight)

  • Storage:

    Store at controlled room temperature between 15º to 30ºC (59º-86ºF).
    Keep container tightly closed when not in use.

  • INFORMATION FOR OWNERS/CAREGIVERS

    Reorder #014676    60 mL  AH-014676-L-04 REV: 0723

    Reorder #014677 120 mL   AH-014677-L-04 REV: 0723

    Reorder #014678​ 240 mL   AH-014678-L-03 REV: 0323


    Questions? (855) 724-3461

    Distributed by:
    Covetrus® North America
    400 Metro Place North
    Dublin, OH 43017
    covetrus.com

  • Description:

    Miconazole nitrate 1% 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%.

  • Precautions:

    In the event of sensitization or irritation due to Miconazole nitrate 1% 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.

    Spray:

    Spray affected areas from a distance of 2 to 4 inches to apply a light covering, once daily for 2 to 4 weeks. Do not allow pet to contact finished wood surfaces until pet is thoroughly dried.
    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.

    Lotion:

    Apply a light covering of Miconazole nitrate 1% 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.
    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.

  • CONTACT INFORMATION:

    To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Covetrus® at (855) 724-3461 or covetrus.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

  • 60 mL

    image of front of container labelimage of back of container labelimage of inner case labelimage of master case label

  • 120 mL

    image of front of container labelimage of back of container labelimage of inner case labelimage of master case label

  • 240 mL

    image of front of container labelimage of back of container labelimage of inner and master case label

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE  1%
    micaonazole spray
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:11695-2221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE11.5 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-2221-272 in 1 CASE
    160 mL in 1 BOTTLE, DROPPER
    2NDC:11695-2221-412 in 1 CASE
    2120 mL in 1 BOTTLE, SPRAY
    3NDC:11695-2221-812 in 1 CASE
    3240 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20036209/21/2023
    Labeler - Butler Animal health Supply, LLC dba Covetrus North America (603750329)
    Establishment
    NameAddressID/FEIBusiness Operations
    FIRST PRIORITY INCORPORATED179925722manufacture, label
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