SUFFUSION K MOUSSE- chlorhexidine gluconate, ketoconazole 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

FOR DOGS & CATS

ANTISEPTIC MOUSSE

ACTIVE INGREDIENTS: Chlorhexidine Gluconate 2%, Ketoconazole 1%.

INACTIVE INGREDIENTS: Water, Glycerin, Polysorbate 20, Propylene Glycol, Lactic Acid, Avena Sativa (Oat) Kernal Extract, Ceramide EOP, Ceramide EOS, Ceramide NP, Fragrance, Potassium Sorbate, Methylisothiazolinone.

PROPERTIES: Suffusion™ K Mousse is a leave-on mousse with chlorhexidine and ketoconazole, antibacterial and antifungal ingredients for antiseptic activity on skin. Skin nourishing nutrients moisturize and calm the skin. They also support the skin's natural immune system, and provide building blocks for renewed skin barrier integrity.

INDICATIONS & USAGE

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

DIRECTIONS FOR 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. Wash hands after use.

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 necessary to cover the whole body, avoiding 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. For deeper cleansing, use Suffusion™ K Shampoo.

WARNINGS AND PRECAUTIONS

CAUTIONS: For external use on dogs and cats only. Avoid contact with eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.

WARNING: 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: 46066-057-15

Pivetal

SUFFUSION™ K

FOR DOGS & CATS

Chlorhexidine Gluconate 2%, Ketoconazole 1%

ANTISEPTIC MOUSSE

ANTIBACTERIAL

ANTIFUNGAL

6.8 fl oz (200 mL)

INGREDIENTS AND APPEARANCE

SUFFUSION  K MOUSSE
chlorhexidine gluconate, ketoconazole liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-057
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LACTIC ACID (UNII: 33X04XA5AT)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-057-15	200 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/16/2021

Labeler - Aspen Veterinary Resource, LTD. (627265361)

Registrant - Ceva Sante Animale (261126049)