Label: SUFFUSION K- chlorhexidine gluconate, ketoconazole spray
- NDC Code(s): 46066-059-90
- 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 April 14, 2021
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DESCRIPTION
Suffusion™ K
FOR DOGS & CATS
ANTISEPTIC SPRAY
ACTIVE INGREDIENTS: Chlorhexidine Gluconate 2%, Ketoconazole 1%.
INACTIVE INGREDIENTS: Water, Glycerin, Polysorbate 20, Propylene Glycol, Lactic Acid, Avena Sativa (Oat) Kernal Extract, Ceramide EOP, Ceramide EOS, Ceramide NP, Fragrance, Potassium Sorbate, Methylisothiazolinone.
PROPERTIES: Suffusion™ K Spray is a leave-on spray with chlorhexidine and ketoconazole, antibacterial and antifungal ingredients for antiseptic activity on the skin. 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 ketoconazole.
DIRECTIONS FOR USE: Apply 1 to 3 times per day for 2-3 weeks or as directed by your veterinarian. Part the fur and spray directly onto the affected area(s) of the skin. Gently smooth product on the skin to ensure full coverage. Do not allow the animal to lick the treated area. Wash hands after use.
- 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
chlorhexidine gluconate, ketoconazole sprayProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-059 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LACTIC ACID (UNII: 33X04XA5AT) AVENANTHRAMIDES (UNII: 5PA41O4AIT) CERAMIDE 1 (UNII: 5THT33P7X7) CERAMIDE EOS (UNII: CR0J8RN66K) CERAMIDE NP (UNII: 4370DF050B) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46066-059-90 237 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/16/2021 Labeler - Aspen Veterinary Resources, LTD. (627265361) Registrant - Ceva Sante Animale (261126049)
