SUFFUSION K- chlorhexidine gluconate, ketoconazole spray

Suffusion by

Drug Labeling and Warnings

Suffusion by is a Animal medication manufactured, distributed, or labeled by Aspen Veterinary Resources, LTD., Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Suffusion™ K

FOR DOGS & CATS

ANTISEPTIC SPRAY

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 Spray is a leave-on spray with chlorhexidine and ketoconazole, antibacterial and antifungal ingredients for antiseptic activity on the 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 or fungal skin infections that are responsive to chlorhexidine or ketoconazole.

DIRECTIONS FOR USE: Apply 1 to 3 times per day for 2-3 weeks or as directed by your veterinarian. Part the fur and spray directly onto the affected area(s) of the skin. Gently smooth product on the skin to ensure full coverage. Do not allow the animal to lick the treated area. Wash hands after use.

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 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: 46066-059-90

SUFFUSION™ K

FOR DOGS AND CATS

Chlorhexidine Gluconate 2%, Ketoconazole 1%

ANTISEPTIC SPRAY

ANTIBACTERIAL

ANTIFUNGAL

8 fl oz (237 mL)

INGREDIENTS AND APPEARANCE

SUFFUSION  K
chlorhexidine gluconate, ketoconazole spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-059
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: 46066-059-90	237 mL in 1 BOTTLE, SPRAY

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

Labeler - Aspen Veterinary Resources, LTD. (627265361)

Registrant - Ceva Sante Animale (261126049)