Label: SUFFUSION K PS- chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl spray
- NDC Code(s): 46066-157-90
- 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 Spray
ACTIVE INGREDIENTS: Chlorhexidine Gluconate 2%, Ketoconazole 1%, Phytosphingosine Salicyloyl 0.02%.
INACTIVE INGREDIENTS: Water, Glycerin, PEG-75 Lanolin, Lactic Acid, Polysorbate 20, Aloe Barbadensis Leaf Juice, Fragrance, Methylisothiazolinone.
PROPERTIES: Suffusion K +PS Spray is rinse-free formulation for the management of bacterial and fungal skin infections. It contains aloe vera to moisturize and phytosphingosine, a pro-ceramide to help support a healthy skin barrier.
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INDICATIONS & USAGE
INDICATION: For use on dogs and cats with skin infections that are responsive to chlorhexidine gluconate and ketoconazole.
DIRECTIONS FOR USE: Apply 1 to 3 times per day for 2-3 weeks or as directed by your veterinarian. Spray directly onto the target area. If needed, part the hair to allow direct contact with the skin. Gently massage into the skin. Do not allow the animal to lick the treated area.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle
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INGREDIENTS AND APPEARANCE
SUFFUSION K PS
chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl sprayProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-157 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 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PEG-75 LANOLIN (UNII: 09179OX7TB) LACTIC ACID (UNII: 33X04XA5AT) POLYSORBATE 20 (UNII: 7T1F30V5YH) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46066-157-90 237 mL in 1 BOTTLE, SPRAY 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)