Label: PHYTO CHX KET FLUSH- ketoconazole, phytosphingosine hydrochloride solution
- NDC Code(s): 11695-7238-4, 11695-7238-6
- 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 November 13, 2019
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- Official Label (Printer Friendly)
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DESCRIPTION
PHYTOVET KET FLUSH
Active Ingredients: Chlorhexidine gluconate 0.2%, ketoconazole 0.2%, phytosphingosine salicyloyl 0.02%.
Inactive Ingredients: Water, propylene glycol, nonoxynol-12, glycerin, lactic acid, polysorbate 20, benzyl alcohol, aloe barbadenis leaf juice, fragrance.
Properties: Phyto CHX+KET antiseptic flush is formulated with chlorhexidine gluconate and ketoconazole, antibacterial and antifungal agents for skin cleansing. It also contains phytosphingosine, a pro-ceramide to help moisturize and support a heatlhy skin barrier.
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INDICATIONS & USAGE
Indications: For use on dogs, cats, and horses only. For antiseptic cleansing of puncture wounds, lacerations, and abrasions. May also be used for skin infections that are responsive to chlorhexidine gluconate and ketoconazole.
Directions for use: Shake well before use. Use twice daily or as directed by your veterinarian. Apply liberally to affected area(s).
Use absorbent material to wipe away excess solution and debris.
Do not allow animal to lick treated area. -
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 CHX KET FLUSH
ketoconazole, phytosphingosine hydrochloride solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-7238 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE 2 mg in 1 mL CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 2 mg in 1 mL SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) SALICYLOYL PHYTOSPHINGOSINE 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NONOXYNOL-12 (UNII: 6NR43D77O6) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) POLYSORBATE 20 (UNII: 7T1F30V5YH) BENZYL ALCOHOL (UNII: LKG8494WBH) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-7238-4 118 mL in 1 BOTTLE, PLASTIC 2 NDC:11695-7238-6 473 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)
