Animal NDC 13985-008-24 Conzol

Miconazole Nitrate

Animal NDC Product Code 13985-008-24

Field Name Field Value
Animal NDC Code 13985-008-24
Proprietary Name Conzol 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 Mwi
Product Type Prescription Animal Drug
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 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.

Conzol Animal Product Label Images

Conzol 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.

Product Labeling Index

Description

ANADA  #200-196, approved by FDA.DESCRIPTION: 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%.

Indications & Usage

INDICATIONS: 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.

Precautions

PRECAUTIONS: In the event of sensitization or irritation due to 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.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.August 1997

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 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.

How Supplied

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

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

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