Animal NDC 54925-031-12 Miconosol
Miconazole Nitrate

Animal Product Information

Field Name Field Value
Animal NDC Code 54925-031-12
Proprietary Name Miconosol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Miconazole Nitrate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Med-pharmex, Inc
Product Type Prescription Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Miconazole Nitrate
Inactive Ingredient(s)
  • POLYETHYLENE GLYCOL 400 (B697894SGQ)
  • POLYETHYLENE GLYCOL 400 (B697894SGQ)
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200196 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Miconosol Images

Miconosol Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.


Other



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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.