SUFFUSION- chlorhexidine gluconate shampoo

SUFFUSION by

Drug Labeling and Warnings

SUFFUSION by is a Animal medication manufactured, distributed, or labeled by ASPEN VETERINARY RESOURCES, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Suffusion™ 4%

FOR DOGS & CATS

Chlorhexidine Gluconate 4%

ANTISEPTIC SHAMPOO

ACTIVE INGREDIENT: Chlorhexidine Gluconate 4%

INACTIVE INGREDIENTS: Water, Lauramine Oxide, Cocamidopropyl Betaine, Polyacrylate-1 Crosspolymer, Disodium Oleamido MIPA Sulfosuccinate, Decyl Glucoside, Glycolic Acid, Avena Sativa (Oat) Kernal Extract, Glycerin, Ceramide EOS, Ceramide EOP, Ceramide NP, Potassium Sorbate, Fragrance, Tetrasodium EDTA, Sodium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 6.

PROPERTIES: Suffusion™ 4% Shampoo is a shampoo with chlorhexidine, an antibacterial and antifungal ingredient for antiseptic skin cleansing. Skin nourishing nutrients moisturiize 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.

DIRECTIONS FOR USE: Bathe 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 the shampoo first on the skin abnormalities. Starting with a quarter-size amount of product, massage in 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.

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 your veterinarian.

WARNING: Keep out of the 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

pivetalvet.com

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

Pivetal

NDC: 46066-038-90

Suffusion™ 4%

FOR DOGS & CATS

Chlorhexidine Gluconate 4%

ANTISEPTIC SHAMPOO

8 fl oz (237 mL)

ANTIBACTERIAL
ANTIFUNGAL

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

Pivetal

NDC: 46066-038-91

Suffusion™ 4%

FOR DOGS & CATS

Chlorhexidine Gluconate 4%

ANTISEPTIC SHAMPOO

16 fl oz (473 mL)

ANTIBACTERIAL
ANTIFUNGAL

INGREDIENTS AND APPEARANCE

SUFFUSION 
chlorhexidine gluconate shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	40 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)
DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F)
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: 46066-038-90	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 46066-038-91	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/02/2021

Labeler - ASPEN VETERINARY RESOURCES (627265361)

Registrant - Ceva Sante Animale (261126049)