SUFFUSION K- chlorhexidine gluconate, ketoconazole 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 Shampoo

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

INACTIVE INGREDIENTS:

Water, Lauramine Oxide, Cocamidopropyl Betaine, Polyacrylate-1 Crosspolymer, Decyl Glucoside, Glycolic Acid, Avena Sativa (Oat) Kernel Extract, Glycerin, Ceramide EOP, Ceramide EOS, Ceramide NP, Potassium Sorbate, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone.

PROPERTIES:

Suffusion™ K Shampoo is a shampoo with chlorhexidine and ketoconazole, antibacterial and antifungal ingredients for antiseptic skin cleansing. 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 and cats with skin infections that are responsive to chlorhexidine gluconate and ketoconazole.

DIRECTIONS FOR USE:

Bathe 2 to 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. Wash hands after use. For a rinse-free solution between baths, ask your veterinarian about Suffusion™ K Wipes, Suffusion™ K Spray, or Suffusion™ K 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.

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

Pivetal®

NDC: 46066-058-90

SUFFUSION™ K

FOR DOGS AND CATS

Chlorhexidine Gluconate 2%, Ketoconazole 1%

ANTISEPTIC SHAMPOO

ANTIBACTERIAL

ANTIFUNGAL

8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

Pivetal®

NDC: 46066-058-90

SUFFUSION™ K

FOR DOGS AND CATS

Chlorhexidine Gluconate 2%, Ketoconazole 1%

ANTISEPTIC SHAMPOO

ANTIBACTERIAL

ANTIFUNGAL

16 fl oz (473 mL)

INGREDIENTS AND APPEARANCE

SUFFUSION  K
chlorhexidine gluconate, ketoconazole shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-058
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)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCOLIC ACID (UNII: 0WT12SX38S)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
GLYCERIN (UNII: PDC6A3C0OX)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-058-90	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 46066-058-91	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/09/2021

Labeler - Aspen Veterinary Resource, LTD. (627265361)

Registrant - Ceva Sante Animale (261126049)