ANADA #200-196, approved by FDA.
DESCRIPTION: Miconazole Nitrate 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 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 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. 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: Miconazole Nitrate Spray in 120 mL and 240 mL containers.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
August 1997
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Miconazole Nitrate | ACTIVE INGREDIENT | VW4H1CYW1K | 1 | |
| Miconazole | ACTIVE MOIETY | 7NNO0D7S5M | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11695-4834 | 11695-4834-2, 11695-4834-4 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Miconazole Nitrate | VW4H1CYW1K | ACTIB |
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