Label: SUFFUSION TRIS FLUSH- ketoconazole, phytosphingosine hydrochloride solution
- NDC Code(s): 46066-166-80, 46066-166-91
- 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 September 27, 2019
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DESCRIPTION
Suffusion TRIS +PS FLUSH
ACTIVE INGREDIENTS: Ketoconazole 0.1%, Phytosphingosine HCl 0.01%.
INACTIVE INGREDIENTS: Water, SDA 40B 190 Proof, Nonoxynol-9, Disodium EDTA, Tromethamine, Methylisothiazolinone.
PROPERTIES: Suffusion TRIS +PS Flush is an antibacterial and antifungal solution for the gentle cleansing of skin and ears. It contains ketoconazole for the management of yeast and fungal infections. TRIS +PS Flush helps break down bacteria cell walls. It also contains phytosphingosine, a pro-ceramide to help moisturize and support a healthy skin barrier.
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INDICATIONS & USAGE
INDICATIONS: For the antiseptic cleansing of skin and ears on dogs and cats.
DIRECTIONS FOR USE: Shake well before use. Apply twice a day or as directed by your veterinarian. Ask your veterinarian which of the following protocols is best for your pet.
Ear cleaning: 1) Moisten a cotton ball with solution and place in entrance of ear canal; OR 2) Hold the ear flap upwards and fill the ear canal with solution. Then gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away debris and excess solution with a clean, dry cotton ball. Skin cleaning: Apply liberally then use absorbent material to gently wipe away excess solution and debris. Repeat as necessary until clean. Do not allow animal to lick the treated area. -
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. Do not use with a suspected ruptured eardrum. Wash hands after use.
WARNING: Keep out of reach of children.
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle
- PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle
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INGREDIENTS AND APPEARANCE
SUFFUSION TRIS FLUSH
ketoconazole, phytosphingosine hydrochloride solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-166 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE 1 mg in 1 mL PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) NONOXYNOL-9 (UNII: 48Q180SH9T) TROMETHAMINE (UNII: 023C2WHX2V) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46066-166-80 118 mL in 1 BOTTLE, PLASTIC 2 NDC:46066-166-91 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/04/2019 Labeler - Aspen Veterinary Resource, LTD. (627265361) Registrant - Ceva Sante Animale (261126049) Establishment Name Address ID/FEI Business Operations Evonik Nutrition & Care GmbH 314906476 api manufacture
