Label: VETRASEB P- pramoxine hydrochloride, phytosphingosine salicyloyl spray
- NDC Code(s): 13985-731-08
- Packager: MWI/VetOne
- 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
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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.
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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
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle
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INGREDIENTS AND APPEARANCE
VETRASEB P
pramoxine hydrochloride, phytosphingosine salicyloyl sprayProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:13985-731 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13985-731-08 237 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/01/2017 Labeler - MWI/VetOne (019926120) Registrant - Ceva Sante Animale (261126049)