Label: SUFFUSION P PS- pramoxine hydrochloride, phytosphingosine salicyloyl spray
- NDC Code(s): 14043-022-08
- Packager: Patterson Veterinary
- 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 March 9, 2017
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DESCRIPTION
Suffusion P +PS Spray
ACTIVE INGREDIENTS: Pramoxine HCI 1%, Phytosphingosine salicyloyl 0.05%.
INACTIVE INGREDIENTS: Water, Glycerin, Silicone Emulsion, Stearamidopropyl Dimethylamine Lactate, PEG-75 Lanolin, Sodium Lactate,
Hydrolyzed Oat Protein, Methylisothiazolinone.PROPERTIES: Suffusion P +PS 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. Suffusion P +PS Spray also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.
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INDICATIONS & USAGE
INDICATIONS: For use on dogs and cats only. For the temporary relief of pruritus and skin irritations.
DIRECTIONS FOR USE: Shake well before 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 beused 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
SUFFUSION P PS
pramoxine hydrochloride, phytosphingosine salicyloyl sprayProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:14043-022 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:14043-022-08 237 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2017 Labeler - Patterson Veterinary (006962500) Registrant - Ceva Sante Animale (261126049)
