SUFFUSION M- chlorhexidine gluconate, miconazole nitrate 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™ M

FOR DOGS AND CATS

ANTISEPTIC SHAMPOO

ACTIVE INGREDIENTS: Chlorhexidine Gluconate 2%, Miconazole Nitrate 2%.

INACTIVE INGREDIENTS: Water, Lauramine Oxide, Cocamidopropyl Betaine, Decyl Glucoside, Polyacrylate-1 Crosspolymer, Lactic Acid, Acetic Acid, Avena Sativa (Oat) Kernel Extract, Glycerin, Ceramide EOP, Ceramide EOS, Ceramide NP, Fragrance, Potassium Sorbate, Sodium Hydroxide, Methylchloroisothiazolinone, Methylisothiazoline.

PROPERTIES: Suffusion™ M Shampoo is a shampoo with chlorhexidine and miconazole, antibacterial and antifungal ingredients for 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 or cats with bacterial or fungal skin infections that are responsive to chlorhexidine or miconazole.

DIRECTIONS FOR USE: Shake well before 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 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, use Suffusion™ M Mousse or Suffusion™ M Wipes.

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

Pivetal®

NDC: 46066-065-90

SUFFUSION™ M

FOR DOGS AND CATS

Chlorhexidine Gluconate 2%, Miconazole Nitrate 2%

ANTISEPTIC SHAMPOO

ANTIBACTERIAL

ANTIFUNGAL

8 FL. OZ. (237 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

Pivetal®

NDC: 46066-065-91

SUFFUSION™ M

FOR DOGS AND CATS

Chlorhexidine Gluconate 2%, Miconazole Nitrate 2%

ANTISEPTIC SHAMPOO

ANTIBACTERIAL

ANTIFUNGAL

16 FL. OZ. (473 mL)

INGREDIENTS AND APPEARANCE

SUFFUSION  M
chlorhexidine gluconate, miconazole nitrate shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-065
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
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
LACTIC ACID (UNII: 33X04XA5AT)
ACETIC ACID (UNII: Q40Q9N063P)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
GLYCERIN (UNII: PDC6A3C0OX)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-065-90	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 46066-065-91	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)