Label: SUFFUSION M MOUSSE- chlorhexidine gluconate, miconazole nitrate liquid
- NDC Code(s): 46066-061-15
- Packager: Aspen Veterinary Resources, LTD
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated May 19, 2021
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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.
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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
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5 OUNCE (148 mL) Bottle
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INGREDIENTS AND APPEARANCE
SUFFUSION M MOUSSE
chlorhexidine gluconate, miconazole nitrate liquidProduct 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)
