PHYTO CHX KET ANTISEPTIC- chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl spray

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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Phyto CHX+KET Antiseptic Spray

Active Ingredients: Chlorhexidine gluconate 2%, ketoconazole 1%, phytosphingosine salicyloyl 0.02%.

Inactive Ingredients: Water, glycerin, PEG-75 lanolin, lactic acid, polysorbate 20, aloe barbadenis leaf juice, fragrance, methylisothiazolinone.

Properties: Phyto CHX+KET spray is formulated with chlorhexidine gluconate and ketoconazole, antibacterial and antifungal agents for the management of skin infections. This no-rinse spray also contains phytosphingosine, a pro-ceramide to help moisturize and support a healthy skin barrier.

INDICATIONS & USAGE

Indications: For use on dogs, cats, and horses only. For the management of bacterial and fungal skin infections responsive to chlorhexidine gluconate and ketoconazole.

Directions for use: Shake well before use. Apply 1 to 3 times per day for 2 to 3 weeks or as directed by your veterinarian. Spray directly onto the target area(s). If needed, part the hair to allow direct contact with the skin. Massage gently into the skin. Do not allow the animal to lick the treated area.

WARNINGS AND PRECAUTIONS

Cautions: For external use on dogs, cats, and horses 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 - 8 OUNCE (237 mL) Bottle

covetrus

NDC: 11695-7226-8

Phyto CHX+KET

Chlorhexidine gluconate 2%, ketoconazole 1%,

phytosphingosine salicyloyl 0.02%

Antiseptic Spray

Antiseptic spray for dogs, cats and horses

For animal use only

Keep out of reach of children

Net contents: 8 fl oz (237 mL)

INGREDIENTS AND APPEARANCE

PHYTO  CHX KET ANTISEPTIC
chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7226
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) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	PHYTOSPHINGOSINE	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-75 LANOLIN (UNII: 09179OX7TB)
LACTIC ACID (UNII: 33X04XA5AT)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7226-8	237 mL in 1 BOTTLE, SPRAY

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)