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Animal NDC 13985-596-24 Conzol 1 %

Micaonazole

Animal Product Information

Field Name Field Value
Animal NDC Code 13985-596-24
Proprietary Name Conzol 1 % 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 Micaonazole 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 Mwi
Product Type Prescription Animal Drug
Usage Information
    Conzol™ Lotion, 1% (miconzole nitrate) & Conzol™ Spray, 1% (miconzole nitrate) is 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
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 ANADA200362 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.

Conzol 1 % Images

Conzol 1 % 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



Information For Owners/Caregivers



Topical antifungal agent for dogs and cats.

Distributed by: MWI
Boise, ID 83705
www.VetOne.net
Rev. 04/23

Approved by FDA under ANADA # 200-362


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


Description:



Conzol™ Lotion, 1% (miconazole nitrate) & Conzol™ Spray, 1% (miconazole nitrate) is a synthetic antifungal agent for use in dogs and cats.  It contains: 1.15% miconzole nitrate (equivalent to 1% miconzole base by weight), polyethylene glycol 400, ethyl alcohol 55%.


Indications:



Conzol™ Lotion, 1% (miconzole nitrate) & Conzol™ Spray, 1% (miconzole nitrate) is 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 Conzol™ Lotion, 1% (miconazole nitrate) & Conzol™ Spray, 1% (miconazole nitrate), 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.

Lotion: Apply a light covering of Conzol™ Lotion, 1% (miconazole nitrate) to affected areas, once daily, for 2 to 4 weeks.  Application is best accomplished using a gauze pad or cotton swab.

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.


Other



ACTIVE INGREDIENT:
Miconazole Nitrate...........1.15%
(equivalent to 1% miconazole base by weight)


Storage:



Store at controlled room temperature between 15°-30°C (59°-86°F). Keep container tightly closed when not in use.


How Supplied:



Lotion:

Conzol™ Lotion, 1% (miconazole nitrate) is available in 30 and 60 mL bottles with droppers.

Spray:

Conzol™ Spray, 1% (miconazole nitrate) is available in 120 mL & 240 mL bottles with spray misters.


Caution:



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


Contact Information:



To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact First Priority, Inc. at (800) 650-4899 or www.prioritycare.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 Bottle/Case Label




120 Ml Bottle/Case Label




240 Ml Bottle/Case Label




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