MICONATRIS FLUSH- miconazole nitrate solution

MiconaTris by

Drug Labeling and Warnings

MiconaTris by is a Animal medication manufactured, distributed, or labeled by VetBiotek, Inc., Sharon Bio-Medicine Limted. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Miconazole 0.1%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Purified Water, Propylene Glycol, PEG-40 Hydroginated castor Oil, Tromethamine (Tris USP), Methylchloroisothiazolinone, Methylisothiazolinone, Disodium EDTA, and N-Octadeanoylphyosphingosine (Ceramide III)

INDICATIONS & USAGE

MiconaTris Flush: Antiseptic topical formulation with astringent, cleansing and drying properties.

PRODUCT DESCRIPTION: MiconaTris Flush uniquely combines Miconazole and Ceramide III in a proprietary formulation with astringent, general cleansing and drying properties. Ceramide III helps support healthy skin.

Antiseptic cleansing flush for dogs and cats with dermatological conditions responsive to Miconazole. MiconaTris Flush may be used for the topical cleansing of puncture wounds, lacerations and abrasions.

DIRECTIONS FOR USE: Apply liberally to affected area. Use any absorbant material to clean excess solution. Do not allow animal to lick the treated areas until dry to prevent ingestion. Apply twice daily or as directed by your veterinarian. Wash hands after use.

GENERAL PRECAUTIONS

PRECAUTIONS: For animal use only. Do not swallow. Avoid contact with eyes or mucous membranes. If contact occurs, rinse thoroughly with water and consult a veterinarian. If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

SPECIES: Dogs and Cats

STORAGE AND HANDLING

STORAGE: Store at room temperature. Protect from freezing.

SPL UNCLASSIFIED SECTION

AVAILABLE THROUGH LICENSED VETERINARIANS ONLY

MANUFACTURED FOR:

VetBiotek Inc., Largo, Florida USA 888-798-2030

www.vetbiotek.com

VBDFM0016       Rev: 02122016 CVS

PRINCIPAL DISPLAY PANEL

MiconaTris Flush

Miconazole 0.1%

Antiseptic Topical Formulation for Cleansing and Flushing of Ears and Skin

Cearmide III

16 oz. (473 mL)

VETBIOTEK
Innovative Solutions

INGREDIENTS AND APPEARANCE

MICONATRIS  FLUSH
miconazole nitrate solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86056-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	1 g  in 1000 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86056-030-04	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 86056-030-16	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2016

Labeler - VetBiotek, Inc. (079730642)

Establishment
Name	Address	ID/FEI	Business Operations
Sharon Bio-Medicine Limted		918572723	api manufacture