SUFFUSION M MOUSSE- chlorhexidine gluconate, miconazole nitrate liquid

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™ M

For Dogs & Cats

Antiseptic Mousse

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

INACTIVE INGREDIENTS: Water, SD Alcohol 40-B, Propylene Glycol, Propylene Glycol Laurate, Polysorbate 80, Benzyl Alcohol, Poloxamer 184, Cocamidopropyl Betaine, Avena Sativa (Oat) Kernel Extract, Ceramide EOP, Ceramide EOS, Ceramide NP, Glycerin, Potasssium Sorbate.

PROPERTIES: Suffusion™ Mousse is a mousse with chlorhexidine and miconazole, 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 or cats with bacterial or fungal skin infections that are responsive to chlorhexidine or miconazole.

DIRECTIONS FOR USE: Shake well before use.Brush the fur and then apply on dry hair. Apply every 3 days for 2-3 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 haircoat 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 dogs. For deeper cleansing, use Suffusion™ M Shampoo.

WARNINGS AND PRECAUTIONS

CAUTIONS:  For external use on dogs or 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

pivetal.com

PRINCIPAL DISPLAY PANEL - 5 OUNCE (148 mL) Bottle

Pivetal

NDC: 46066-061-15

Suffusion™ M

FOR DOGS & CATS

Chlorhexidine Gluconate 2%, Miconazole Nitrate 2%

ANTISEPTIC MOUSE

ANTIBACTERIAL

ANTIFUNGAL

Net contents: 5 fl oz (147 mL)

INGREDIENTS AND APPEARANCE

SUFFUSION  M MOUSSE
chlorhexidine gluconate, miconazole nitrate liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-061
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)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLOXAMER 184 (UNII: BIS92ZSF57)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-061-15	148 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/21/2021

Labeler - Aspen Veterinary Resources, LTD (627265361)

Registrant - Ceva Sante Animale (261126049)