SUFFUSION K PS MOUSSE- chlorhexidine gluconate, ketoconazole, 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

Suffusion K +PS Mousse

ACTIVE INGREDIENTS: Chlorhexidine Gluconate 2%, Ketoconazole 1%, Phytosphingosine Salicyloyl 0.05%.

INACTIVE INGREDIENTS: Water, Propylene Glycol, Glycerin, Polysorbate 20, Lactic Acid, Fragrance, Methylisothiazolinone.

PROPERTIES: Suffusion K +PS Mousse is a formulation designed to manage skin infections without bathing. It is soap-free, rubbing alcohol-free and moisturizing. Suffusion K +PS Mousse also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS & USAGE

INDICATIONS: For the management of bacterial and fungal skin infections on 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 to 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 into the skin until fully penetrated. Repeat as many times and 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

11-88 lbs: 1 pump per 4 lbs

Over 88 lbs: 1 pump per 6 lbs

Dosage may be doubled for long-haired breeds.

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.

WARNINGS: Keep out of reach of children.

STORAGE AND HANDLING

STORAGE CONDITIONS: Store at controlled 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: 460066-155-14

SUFFUSION™

K +PS Mousse

Chlorhexidine Gluconate 2%, Ketoconazole 1%, Phytosphingosine Salicyloyl 0.05%

Antiseptic Mousse

FOR CATS & DOGS

Phytosphingosine

Wellness

PIVETAL 

SHAKE WELL BEFORE USE

6.8 FL. OZ. (200 mL)

INGREDIENTS AND APPEARANCE

SUFFUSION  K PS MOUSSE
chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-155
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-155-14	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)