Your browser does not support JavaScript! MICONOSOL (MICONAZOLE NITRATE) LOTION [MED-PHARMEX, INC]

Veterinary Medicine Labels  

                Current Medication Information

Options

RxNorm Names

MICONOSOL (miconazole nitrate) lotion
[Med-Pharmex, Inc]


Category DEA Schedule Marketing Status
PRESCRIPTION ANIMAL DRUG LABEL Abbreviated New Animal Drug Application
Drug Label Sections

Description

MICONAZOLE NITRATE lotion 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

MICONAZOLE NITRATE Lotion is indicated for the treatment of fungal lnfections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes.

Precautions

In the event of sensitization or irritation due to MICONAZOLE NITRATE Lotion, 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. ldentification 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.

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.

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

M1CONAZOLE NITRATE Lotion in 60 mL containers.

Caution

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

Miconosol Lotion 1%

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


Miconazole Lotion Insert.


Miconosol Lotion 60mL Label


MICONOSOL 
miconazole nitrate lotion
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54925-031
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate1.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
POLYETHYLENE GLYCOL 400 
Packaging
#Item CodePackage Description
1NDC:54925-031-0660 mL in 1 BOTTLE
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, Inc025353699manufacture

Revised: 10/2012
 
Med-Pharmex, Inc

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services