SUFFUSION P PS MOUSSE- pramoxine hydrochloride, phytosphingosine salicyloyl liquid

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

Pramosoothe +PS Mousse

ACTIVE INGREDIENTS: Pramoxine HCl 1%, Phytosphingosine Salicloyl 0.05%.

INACTIVE INGREDIENTS: Water, Glycerin, PEG-8 Dimethicone, Polysorbate 80, Poloxamer 184, Sodium Lactate, Hydrolyzed Oat Protein,  Fragrance, Aloe Barbadensis (Aloe) Leaf Extract, Methylisothiazolinone.

PROPERTIES: Pramosoothe +PS Mousse is designed for the temporary relief of itching without rinsing. It contains praamoxine, a mild numbing agent, as well as colloidal oatmeal to soothe irritated skin. It also contains phytosphingosine, a pro-ceramide to moisturize and help support a healthy skin barrier.

INDICATIONS & USAGE

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

DIRECTIONS FOR USE: Shake well before use. Brush the fur and then apply on dry hair. Apply every 3 days for 2-3 weeks or as directed by your veterinarian.

For localized application:Dispense 1 or 2 pumps onto your palm and then apply on the targeted area(s). Massage into the skin until fully penetrated. Do not rinse, let air dry. Once dry, brush the fur again.

For whole body application:  Dispense 1 or 2 pumps onto your palm and then apply on the skin and hair. Massage gently into the skin until fully penetrated. Repeat as many times as necessary to cover the whole body, avoiding areas around the eyes and mouth. Do not rinse, let air dry. Once dry, brush the fur again.

Dosage:

Under 11 lbs: 1 pump per 2 lbs

12-88 lbs: 1 pump per 4 lbs

Over 88 lbs: 1 pump per 6 lbs

Dosage may be doubled for long-haired dogs.

WARNINGS AND PRECAUTIONS

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 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 - 6.8 OUNCE (200 mL) Bottle

NDC: 46066-165-14

SUFFUSION™

P +PS Mousse

Pramoxine HCl 1%, Phytosphingosine Salicloyl 0.05%

Soothing Mousse

FOR CATS & DOGS

Phytosphingosine

Wellness

BY PIVETAL 

SHAKE WELL BEFORE USE

6.8 FL. OZ. (200 mL)

INGREDIENTS AND APPEARANCE

SUFFUSION  P PS MOUSSE
pramoxine hydrochloride, phytosphingosine salicyloyl liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-165
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)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
SODIUM LACTATE (UNII: TU7HW0W0QT)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLOXAMER 184 (UNII: BIS92ZSF57)
OAT (UNII: Z6J799EAJK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-165-14	200 mL in 1 BOTTLE, PLASTIC

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

Labeler - Aspen Veterinary Resource, LTD. (627265361)

Registrant - Ceva Sante Animale (261126049)