SUFFUSION PS HYPO-ALLERGENIC- phytosphingosine salicyloyl shampoo 
Aspen Veterinary Resource, LTD.

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.

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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.

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.

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 CONDITIONS: Store at room temperature. Do not freeze.

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)

8 ounce bottle label

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)

16 ounce bottle label

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)

1 gallon jug label

SUFFUSION  PS HYPO-ALLERGENIC
phytosphingosine salicyloyl shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46066-167
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46066-167-90237 mL in 1 BOTTLE, PLASTIC
2NDC:46066-167-91473 mL in 1 BOTTLE, PLASTIC
3NDC:46066-167-933785 mL in 1 JUG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/27/2019
Labeler - Aspen Veterinary Resource, LTD. (627265361)
Registrant - Ceva Sante Animale (261126049)

Revised: 9/2019
Document Id: a76e6162-5528-44fe-9fce-55eb3fdf5ac6
Set id: 512c74cd-51dc-4a60-ac4c-388d33e8bf1c
Version: 1
Effective Time: 20190923
 
Aspen Veterinary Resource, LTD.