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 spray 
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 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 formulated for the temporary relief of itching in dogs and cats. It contains pramoxine HCl, a mild numbing agent, and colloidal oatmeal to soothe irritated skin. Suffusion P +PS Spray also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

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

DIRECTIONS FOR USE: Shake well before use. Apply 1-3 times per day or as recommended by your veterinarian. Spray directly onto the target area. If needed, part the hair to allow direct contact with the skin. Massage gently into the skin. Do not allow the animal to lick the treated area.

CAUTIONS: For external use on dogs and cats only. Avoid contact with eyes. If eye contat 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: 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: 46066-163-90

SUFFUSION™

P +PS Spray

Pramoxine HCl 1%,

Phytosphingosine Salicyloyl 0.05%

Soothing Spray

FOR CATS & DOGS

Phytosphingosine

Wellness

BY PIVETAL

Net Contents: 8 FL. OZ. (237 mL)

SUFFUSION  P PS
pramoxine hydrochloride, phytosphingosine salicyloyl spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-163
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: 46066-163-90	237 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/11/2019	03/25/2020

Labeler - Aspen Veterinary Resource, LTD. (627265361)

Registrant - Ceva Sante Animale (261126049)

Revised: 3/2020

Document Id: 4a6ccb8a-904f-4538-9669-bf08ee8ddbbb

50577-6

Set id: 3f92685e-4685-446c-b973-9fe388d00662

Version: 2

Effective Time: 20200325