SUFFUSION K PS- chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl shampoo

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 Shampoo

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

INACTIVE INGREDIENTS: Water, Lauramine Oxide, Cocamidopropyl Betaine, Polyacrylate-1 Crosspolymer, Decyl Glucoside, Glycolic Acid, Fragrance, Tetrasodium EDTA, Sodium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone.

PROPERTIES: Suffusion K +PS Shampoo is formulated for antibacterial and antifungal skin cleansing. This low-lather formula contains phytosphingosine, a pro-ceramide to help moisturize and support a healthy skin barrier.

INDICATIONS & USAGE

INDICATIONS: For use on dogs and cats with skin infections that are responsive to chlorhexidine gluconate and ketoconazole.

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 K +PS Spray or Mousse. 

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 - 8 OUNCE (237 mL) Bottle

NDC: 46066-154-90

SUFFUSION™

K +PS Shampoo

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

Antiseptic Shampoo

FOR CATS & DOGS

Phytosphingosine

Wellness

PIVETAL 

8 FL. OZ. (237 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

NDC: 46066-154-91

SUFFUSION™

K +PS Shampoo

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

Antiseptic Shampoo

FOR CATS & DOGS

Phytosphingosine

Wellness

PIVETAL

16 FL. OZ. (473 mL)

INGREDIENTS AND APPEARANCE

SUFFUSION  K PS
chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-154
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) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	PHYTOSPHINGOSINE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCOLIC ACID (UNII: 0WT12SX38S)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-154-90	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 46066-154-91	473 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)