Miconazole Nitrate 1%: Product Information
MICONAZOLE NITRATE 1%- miconazole nitrate spray
Butler Animal health Supply, LLC dba Covetrus North America
Lotion/Spray
Topical antifungal agent for dogs and cats
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:
Miconazole nitrate 1% Lotion/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:
Miconazole nitrate 1% Lotion/Spray 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 Miconazole nitrate 1% Lotion/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.
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.
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.
Active ingredient:
Miconazole nitrate . . . . . . . . . . . . . . 1.15%
(equivalent to 1% miconazole base by weight)
Storage:
Store at controlled room temperature between 15º to 30ºC (59º-86ºF). Keep container tightly closed when not in use.
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 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
Reorder #014678, AH-014678-L-03, REV: 0323, 2 fl oz (60 mL)
Reorder #014676, AH-014676-L-03, REV: 0323, 4 fl oz (120 mL)
Reorder #014677, AH-014677-L-03, REV: 0323, 8 fl oz (240 mL)
Questions? (855) 724-3461
Distributed by:
Covetrus® North America
400 Metro Place North
Dublin, OH 43017
covetrus.com
Lot No. / Exp. Date
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| Labeler — Butler Animal health Supply, LLC dba Covetrus North America (603750329) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| FIRST PRIORITY INCORPORATED | 179925722 | manufacture, label | |
Revised: 11/2023 Butler Animal health Supply, LLC dba Covetrus North America
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