PHYTO CHX KET FLUSH- ketoconazole, phytosphingosine hydrochloride solution

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

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.

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

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 - 4 OUNCE (118 mL) Bottle

covetrus

NDC: 11695-7238-4

Phyto CHX+KET

Chlorhexidine gluconate 0.2%, ketoconazole 0.2%, Phytosphingosine salicyloyl 0.02%

Antiseptic Flush

Topical antiseptic flushing solution for dogs, cats and horses

For animal use only

Keep out of reach of children

Net Contents: 4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

covetrus

NDC: 11695-7238-6

Phyto CHX+KET

Chlorhexidine gluconate 0.2%, ketoconazole 0.2%, Phytosphingosine salicyloyl 0.02%

Antiseptic Flush

Topical antiseptic flushing solution for dogs, cats and horses

For animal use only

Keep out of reach of children

Net Contents: 16 fl oz (473 mL)

INGREDIENTS AND APPEARANCE

PHYTO  CHX KET FLUSH
ketoconazole, phytosphingosine hydrochloride solution

Product 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)