MICONAZOLE NITRATE 1%- micaonazole spray 
Butler Animal health Supply, LLC dba Covetrus North America

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Miconazole
nitrate 1%

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

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.

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Lot No. / Exp. Date

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.

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

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

60 mL

image of front of container labelimage of back of container labelimage of inner case labelimage of master case label

120 mL

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240 mL

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MICONAZOLE NITRATE  1%
micaonazole spray
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:11695-2221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE11.5 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-2221-272 in 1 CASE
160 mL in 1 BOTTLE, DROPPER
2NDC:11695-2221-412 in 1 CASE
2120 mL in 1 BOTTLE, SPRAY
3NDC:11695-2221-812 in 1 CASE
3240 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20036209/21/2023
Labeler - Butler Animal health Supply, LLC dba Covetrus North America (603750329)
Establishment
NameAddressID/FEIBusiness Operations
FIRST PRIORITY INCORPORATED179925722manufacture, label

Revised: 3/2024
Document Id: ca018402-dca5-4be8-a628-b87f06bca1e4
Set id: d7e2307f-d280-4a86-859d-99ecdfce3158
Version: 11
Effective Time: 20240311
 
Butler Animal health Supply, LLC dba Covetrus North America