Label: BIOTRIS FLUSH- miconazole nitrate solution

  • NDC Code(s): 86056-031-04, 86056-031-16
  • Packager: VetBiotek, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 8, 2018

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: Miconazole Nitrate 0.1%

  • INACTIVE INGREDIENT

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

  • INDICATIONS & USAGE

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

    PRODUCT DESCRIPTION: BioTris 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. BioTris 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

    VBDFM0004/ VBDFM0016      Rev: 10202016 CVS

  • PRINCIPAL DISPLAY PANEL

    BioTris Flush

    Miconazole 0.1%

    Antiseptic Topical Formulation for Cleansing and Flushing of Ears and Skin

    Cearmide III

    4 oz. (118 mL) / 16 oz. ( 473 mL)

    VETBIOTEK
    Innovative Solutions

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  • INGREDIENTS AND APPEARANCE
    BIOTRIS  FLUSH
    miconazole nitrate solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86056-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE1 g  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86056-031-04118 mL in 1 BOTTLE, PLASTIC
    2NDC:86056-031-16473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2017
    Labeler - VetBiotek, Inc. (079730642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Hanpu Pharmaceutical Co654030428api manufacture
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