Label: SUFFUSION K PS MOUSSE- chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl liquid
- NDC Code(s): 46066-155-14
- Packager: Aspen Veterinary Resource, 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 October 8, 2019
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DESCRIPTION
Suffusion K +PS Mousse
ACTIVE INGREDIENTS: Chlorhexidine Gluconate 2%, Ketoconazole 1%, Phytosphingosine Salicyloyl 0.05%.
INACTIVE INGREDIENTS: Water, Propylene Glycol, Glycerin, Polysorbate 20, Lactic Acid, Fragrance, Methylisothiazolinone.
PROPERTIES: Suffusion K +PS Mousse is a formulation designed to manage skin infections without bathing. It is soap-free, rubbing alcohol-free and moisturizing. Suffusion K +PS Mousse also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.
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INDICATIONS & USAGE
INDICATIONS: For the management of bacterial and fungal skin infections on dogs and cats.
DIRECTIONS FOR USE: Shake well before use. Brush the fur and then apply on dry hair. Apply every 3 days for 2 to 3 weeks or as directed by your veterinarian.
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 fur 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 many times and necessary to cover the whole body, avoiding areas around 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 breeds.
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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. Wash hands after use.
WARNINGS: Keep out of reach of children.
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 6.8 OUNCE (200 mL) Bottle
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INGREDIENTS AND APPEARANCE
SUFFUSION K PS MOUSSE
chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-155 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 SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) POLYSORBATE 20 (UNII: 7T1F30V5YH) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46066-155-14 200 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/11/2019 Labeler - Aspen Veterinary Resource, LTD. (627265361) Registrant - Ceva Sante Animale (261126049)
