SUFFUSION PS HYPO-ALLERGENIC- phytosphingosine salicyloyl shampoo

Suffusion by

Drug Labeling and Warnings

Suffusion by is a Animal medication manufactured, distributed, or labeled by Aspen Veterinary Resource, LTD., Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

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

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

SPL UNCLASSIFIED SECTION

QUESTIONS? 1-800-999-0297

Pivetal

Distributed by:

Aspen Veterinary Resources®, LTD.

Liberty, MO 64068

www.pivetalvet.com

PRINCIPAL DISPLAY PANEL - 8 OUNCE BOTTLE

NDC: 46066-167-91

SUFFUSION™

Hypo-Allergenic

+PS Shampoo

Phytosphingosine Salicyloyl 0.02%

Cucumber Melon Scent

Moisturizing Shampoo

FOR CATS & DOGS

Phytosphingosine

Wellness

BY PIVETAL

Net Content: 8 FL. OZ. (237 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE BOTTLE

NDC: 46066-167-91

SUFFUSION™

Hypo-Allergenic

+PS Shampoo

Phytosphingosine Salicyloyl 0.02%

Cucumber Melon Scent

Moisturizing Shampoo

FOR CATS & DOGS

Phytosphingosine

Wellness

BY PIVETAL

Net Content: 16 FL. OZ. (473 mL)

PRINCIPAL DISPLAY PANEL - 1 GALLON JUG

NDC: 46066-167-93

Suffusion™

Hypo-Allergenic

+PS Shampoo

Phytosphingosine Salicyloyl 0.02%

Cucumber Melon Scent

Moisturizing Shampoo

FOR CATS & DOGS

Phytosphingosine

Wellness

BY PIVETAL

1 GALLON (3.785 L)

INGREDIENTS AND APPEARANCE

SUFFUSION  PS HYPO-ALLERGENIC
phytosphingosine salicyloyl shampoo

Product 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)