Label: PHYTO CHX KET ANTISEPTIC MOUSSE- chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl liquid
- NDC Code(s): 11695-7232-2
- 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 14, 2019
If you are a consumer or patient please visit this version.
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DESCRIPTION
PHYTO CHX+KET ANTISEPTIC MOUSSE
Active Ingredients: Chlorhexidine gluconate 2%, ketoconazole 1%, phytosphingosine salicyloyl 0.05%.
Inactive Ingredients: Water, propylene glycol, glycerin, polysorbate 20, lactic acid, fragrance, methylisothiazolinone.
Properties:Phyto CHX+KET antiseptic mousse is formulated with chlorexidine gluconate and ketoconazole, antibacterial and antifungal agents for the management of skin infections. This no-rinse mousse also contains phytosphingosine, a pro-ceramide to help moisturize and support a healthy skin barrier.
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INDICATIONS & USAGE
Indications: For use on dogs and cats only. For the management of bacterial and fungal skin infections responsive to chlorhexidine gluconate and ketoconazole.
Directions for use: Shake well before use. Brush the fur then apply product on dry hair. Apply every 3 days for 2-3 weeks or as directed by your veterinarian.
For localized application: Dispense 1 to 2 pumps onto your palm, then apply on the targeted area(s). Massage into the skin until fully penetrated. Do not rinse, let air dry. Once dry, brush the fur again.
For whole body application: Dispense 1 to 2 pumps onto your palm and massage onto the skin. Repeat as many times as necessary to cover the whole body, avoiding the eyes and mouth. Do not rinse, let air dry. Once dry, brush the fur again.
Dosage:
Under 11 lbs: 1 pump per 2 lbs
11 - 88 lbs: 1 pump per 4 lbs
Over 88 lbs: 1 pump per 6 lbsDosage may be doubled for long-haired breeds.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 6.8 fl oz (200 mL)
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INGREDIENTS AND APPEARANCE
PHYTO CHX KET ANTISEPTIC MOUSSE
chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-7232 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 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) POLYSORBATE 20 (UNII: 7T1F30V5YH) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-7232-2 200 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) Establishment Name Address ID/FEI Business Operations Evonik Nutrition & Care GmbH 314906476 api manufacture
