Label: VETRASEB M- chlorhexidine gluconate, miconazole nitrate, phytosphingosine salicyloyl shampoo

  • NDC Code(s): 13985-726-08, 13985-726-16
  • Packager: MWI/VetOne
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 9, 2019

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  • DESCRIPTION

    VetraSeb™ M SHAMPOO

    ACTIVE INGREDIENTS: Chlorhexidine Gluconate 2%, Miconazole Nitrate 2%, Phytosphingosine salicyloyl 0.05%.

    INACTIVE INGREDIENTS: Water, Lauramine Oxide, Cocamidopropyl Betaine, Decyl Glucoside, Polyacrylate-1 Crosspolymer, Lactic Acid, Acetic Acid, Fragrance, Methylchloroisothiazolinone, Methylisothiazoline, Sodium Hydroxide.

    PROPERTIES: VetOne® VetraSebTM M Shampoo combines the unique properties of Phytosphingosine with antibacterial and antifungal agents for management of skin conditions.

  • INDICATIONS & USAGE

    INDICATIONS: For use on dogs and cats only. For the management of dermatological conditions associated with infections responsive to
    Chlorhexidine Gluconate and Miconazole Nitrate.

    DIRECTIONS FOR USE: Shake well before use. Wet the animal with cool water and massage the shampoo first on the areas with skin abnormalities, then on the rest of the body. Leave the shampoo on for 10 minutes then rinse with cool water. Use 2-3 times per week until symptoms subside or as directed by your veterinarian.

  • WARNINGS AND PRECAUTIONS

    CAUTIONS: For external use on dogs and cats only. Avoid contact with the eyes. In case of contact with eyes, rinse thoroughly and consult your
    veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.

    WARNING: Keep out of the reach of children.

  • STORAGE AND HANDLING

    STORAGE CONDITIONS: Store at room temperature. Do not freeze.

  • SPL UNCLASSIFIED SECTION

    Distributed by: MWI
    Boise, Idaho 83705
    www.VetOne.net
    Questions?
    1-800-999-0297

  • PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

    NDC 3985-726-08

    VETONE®

    VetraSeb™ M

    Shampoo

    Chlorhexidine Gluconate 2%, Miconazole Nitrate 2%,

    Phytosphingosine salicyloyl 0.05%

    Antibacterial and Antifungal Shampoo +PS

    for Dogs and Cats

    For veterinary use only

    Phytosphingosine

    Net Contents: 8 FL. OZ. (237 mL)

    8 ounce bottle label

  • PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

    NDC 3985-726-16

    VETONE®

    VetraSeb™ M

    Shampoo

    Chlorhexidine Gluconate 2%, Miconazole Nitrate 2%,
    Phytosphingosine salicyloyl 0.05%

    Antibacterial and Antifungal Shampoo +PS
    for Dogs and Cats

    For veterinary use only

    Phytosphingosine

    Net Contents: 16 FL. OZ. (473 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    VETRASEB  M
    chlorhexidine gluconate, miconazole nitrate, phytosphingosine salicyloyl shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13985-726
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 mL
    SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-726-08237 mL in 1 BOTTLE, PLASTIC
    2NDC:13985-726-16473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2017
    Labeler - MWI/VetOne (019926120)
    Registrant - Ceva Sante Animale (261126049)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lab Express International800875106api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Evonik Nutrition and Care GmbH314906476api manufacture
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