Label: VETRASEB P- pramoxine hydrochloride, phytosphingosine salicyloyl spray

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 7, 2017

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    VetraSeb™ P Spray

    ACTIVE INGREDIENTS: Pramoxine HCl 1%, Phytosphingosine salicyloyl 0.05%.

    INACTIVE INGREDIENTS: Water, Glycerin, Silicone Emulsion, Stearamidopropyl Dimethylamine Lactate, PEG-75 Lanolin, Sodium Lactate, Hydrolyzed Oat Protein, Methylisothiazolinone.

    PROPERTIES:

    VetraSeb™ P Spray is a solution designed for the temporary relief of itching in dogs and cats. It is alcohol free and contains colloidal oatmeal and moisturizers to further soothe irritation. VetraSeb™ P Spray also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

  • INDICATIONS & USAGE

    INDICATION: For use on dogs and cats only. For the temporary relief of pruritis and skin irritations.

    DIRECTIONS FOR USE: Spray directly onto the target area. If needed, ruffle or part the hair to allow direct contact with the skin. Massage well. Do not allow the animal to lick the treated area until dry. Apply once a day for 2 to 3 weeks or as recommended by your veterinarian. May be used as part of a management plan as recommended 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: 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 13985-731-08

    VETONE®

    VetraSeb™ P

    Spray

    Pramoxine HCl 1%,

    Phytosphingosine salicyloyl 0.05%

    Soothing Spray +PS

    for Dogs and Cats

    For veterinary use only

    Phytosphingosine

    8 FL. OZ. (237 mL)

    8 ounce spray label

  • INGREDIENTS AND APPEARANCE
    VETRASEB  P
    pramoxine hydrochloride, phytosphingosine salicyloyl spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13985-731
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARAMIDOPROPYL DIMETHYLAMINE LACTATE (UNII: 31Q9363QSX)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    OATMEAL (UNII: 8PI54V663Y)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-731-08237 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2017
    Labeler - MWI/VetOne (019926120)
    Registrant - Ceva Sante Animale (261126049)