Animal NDC 11695-2221-4 Miconazole Nitrate 1%

Table of Contents

• Veterinary Indications
• Precautions
• How Supplied
• Indications:
• Dosage:
• Information For Owners/Caregivers
• Active Ingredient:
• Storage:
• Description:
• Precautions:
• Dosage And Administration:
• Spray:
• Lotion:
• Contact Information:
• 60 Ml
• 120 Ml
• 240 Ml

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

Lot No. / Exp. Date

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

Active Ingredient:

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

Storage:

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

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

120 Ml