Label: SUFFUSION PS HYPO-ALLERGENIC- phytosphingosine salicyloyl shampoo
- NDC Code(s): 46066-167-90, 46066-167-91, 46066-167-93
- Packager: Aspen Veterinary Resource, LTD.
- 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 September 23, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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DESCRIPTION
Suffusion Hypo-Allergenic +PS Shampoo
ACTIVE INGREDIENT: Phytosphingosine Salicyloyl 0.02%.
INACTIVE INGREDIENTS: Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Chloride, Sodium Lactate, Fragrance, Glycerin, Disodium Cocoamphodiacetate, Propylene Glycol, Hydroxypropyl Methylcellulose, Citric Acid, Tetrasodium EDTA, Carthamus Tinctorius (Safflower) Seed Oil, Methylchloroisothiazolinone, Methylisothiazolinone.
PROPERTIES: Suffusion Hypo-Allergenic +PS Shampoo is a hypoallergenic, low-lather formulation for grooming and moisturizing. It contains emollients and fatty acids to soothe and nourish the skin and aid in the control of flaking and skin irritations. Suffusion Hypo-Allergenic +PS Shampoo also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.
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INDICATIONS & USAGE
INDICATION: For grooming and moisturizing dry or sensitive skin on dogs and cats.
DIRECTIONS FOR USE: Bathe as needed or as recommended by your veterinarian. Wet the animal with lukewarm water from the neck down. Starting with a quarter-sized amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Rinse thorughly with clean, lukewarm water until the water runs clear.
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WARNINGS AND PRECAUTIONS
CAUTIONS: For external use on dogs and cats only. Avoid contact with the eyes. If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Wash hands after use.
WARNING: Keep out of reach of children.
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 OUNCE BOTTLE
- PRINCIPAL DISPLAY PANEL - 16 OUNCE BOTTLE
- PRINCIPAL DISPLAY PANEL - 1 GALLON JUG
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INGREDIENTS AND APPEARANCE
SUFFUSION PS HYPO-ALLERGENIC
phytosphingosine salicyloyl shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-167 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) SODIUM LACTATE (UNII: TU7HW0W0QT) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) EDETATE SODIUM (UNII: MP1J8420LU) SAFFLOWER OIL (UNII: 65UEH262IS) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46066-167-90 237 mL in 1 BOTTLE, PLASTIC 2 NDC:46066-167-91 473 mL in 1 BOTTLE, PLASTIC 3 NDC:46066-167-93 3785 mL in 1 JUG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/27/2019 Labeler - Aspen Veterinary Resource, LTD. (627265361) Registrant - Ceva Sante Animale (261126049)
