PHYTO CHX KET ANTISEPTIC MOUSSE- chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl liquid

PHYTO by

Drug Labeling and Warnings

PHYTO by is a Animal medication manufactured, distributed, or labeled by Butler Animal Health Supply, LLC dba Covetrus North America, Ceva Sante Animale, Evonik Nutrition & Care GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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 lbs

Dosage may be doubled for long-haired breeds.

WARNINGS AND 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. Wash hands after use.

STORAGE AND HANDLING

Storage: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

Questions? (855) 724-3461

Distributed by:
Covetrus North America
400 Metro Place North
Dublin, OH 43017
covetrus.com

PRINCIPAL DISPLAY PANEL - 6.8 fl oz (200 mL)

covetrus

NDC: 11695-7232-2

Phyto CHX+KET

Chlorhexidine gluconate 2%, ketoconazole 1%,

phytosphingosine salicyloyl 0.05%

Antiseptic Mousse

Antiseptic mousse for dogs and cats

For animal use only

Keep out of reach of children

SHAKE WELL BEFORE USE

Net contents: 6.8 fl oz (200 mL)

INGREDIENTS AND APPEARANCE

PHYTO  CHX KET ANTISEPTIC MOUSSE
chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl liquid

Product 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