Suffusion by Aspen Veterinary Resource, LTD. / Ceva Sante Animale

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]

SUFFUSION P PS- pramoxine hydrochloride, 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 P +PS Shampoo

ACTIVE INGREDIENTS: Pramoxine HCI 1%, Phytosphingosine Salicyloyl 0.05%.

INACTIVE INGREDIENTS: Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Glycerin, Sodium Lactate, Hydroxypropyl Methylcellulose, Tetrasodium EDTA, Fragrance, Hydrolyzed Oat Protein, Carthamus Tinctorius (Safflower) Seed Oil, Citric Acid, Sodium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone.

PROPERTIES: Suffusion P +PS Shampoo is formulated for the temporary relief of itching. This low-lather formula contains pramoxine HCl, a mild numbing agent, as well as colloidal oatmeal and essential fatty acids to further soothe irritated skin. Suffusion P +PS Shampoo also contains phytosphingosine, a pro-ceramide to help moisturize and support a healthy skin barrier.

INDICATIONS: For the temporary relief of itching and skin irritations in dogs and cats.

DIRECTIONS FOR USE:  Use 2-3 times per week until symptoms subside or as directed by your veterinarian.Wet the animal with cool water from the neck down and apply shampoo first on the skin abnormalities. Starting with a quarter-size amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Leave shampoo on for 10 minutes before rinsing with cool water until the water runs clear. For a rinse-free solution between baths, ask your veterinarian about Suffusion P +PS Spray or Mousse.

CAUTIONS: For external use on dogs and cats only. Avoid contact with 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 (237 mL) Bottle

NDC: 46066-164-90

SUFFUSION™

+PS Shampoo

Pramoxine HCl 1%, Phytosphingosine Salicyloyl 0.05%

Soothing Shampoo

FOR CATS & DOGS

Phytosphingosine

Wellness

BY PIVETAL 

8 FL. OZ. (237 mL)

8 ounce bottle label

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

NDC: 46066-164-91

SUFFUSION™

P +PS Shampoo

Pramoxine HCl 1%, Phytosphingosine Salicyloyl 0.05%

Soothing Shampoo

FOR CATS & DOGS

Phytosphingosine

Wellness

 BY PIVETAL 

16 FL. OZ. (473 mL)

16 ounce bottle label

SUFFUSION  P PS
pramoxine hydrochloride, phytosphingosine salicyloyl shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC: 46066-164
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) SALICYLOYL PHYTOSPHINGOSINE0.5 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)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
OATMEAL (UNII: 8PI54V663Y)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 46066-164-90237 mL in 1 BOTTLE, PLASTIC
2NDC: 46066-164-91473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/11/201909/01/2024
Labeler - Aspen Veterinary Resource, LTD. (627265361)
Registrant - Ceva Sante Animale (261126049)

Revised: 10/2024