Label: PHYTO KET- ketoconazole, phytosphingosine hydrochloride solution
- NDC Code(s): 11695-7222-4, 11695-7222-6
- Packager: Butler Animal Health Supply, LLC dba Covetrus North America
- 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 December 19, 2019
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- Official Label (Printer Friendly)
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DESCRIPTION
Phyto KET Antiseptic Flush
Active ingredients: Ketoconazole 0.1%, phytosphingosine HCI 0.01%.
Inactive ingredients: Water, SDA 40B 190 proof, nonoxynol-9, disodium EDTA, tromethamine, methylisothiazolinone.
Properties: Phyto KET antiseptic flush is an antiseptic (antibacterial and antifungal) solution for gentle cleansing and flushing of ears and skin. Contains ketoconazole for the management of yeasts and fungi, and preservatives for antibacterial activity. It also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier. Phytosphingosine HCl also has antiseptic properties.
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INDICATIONS & USAGE
Indications: For the antiseptic cleansing of skin and ears.
Directions for use: Shake well before use.
Skin cleaning: Apply liberally to the affected area(s). Use cotton or absorbent material to clean excess solution and wipe away debris. Do not allow the animal to lick the treated area until dry to prevent ingestion.
Ear flushing: Instill liberally into the ear canal while keeping the ear flap up. Gently massage the base of the ear for a few seconds. Wipe the interior flap with cotton or gauze.
Apply twice daily or as directed by your veterinarian. Wash hands after use.
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PRECAUTIONS
Cautions: For external use on dogs, cats, and horses only. Avoid contact with the 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 in the case of a suspected ruptured eardrum.
- 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
PHYTO KET
ketoconazole, phytosphingosine hydrochloride solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-7222 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:11695-7222-4 118 mL in 1 BOTTLE, PLASTIC 2 NDC:11695-7222-6 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2020 Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329) Registrant - Ceva Sante Animale (261126049)
