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

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 Shampoo

Active Ingredrients: Chlorhexidine gluconate 2%, ketoconazole 1%, phytosphingosine salicyloyl 0.05%.

Inactive Ingredients: Water, lauramine oxide, cocamidopropyl betaine, polyacrylate-1 crosspolymer, decyl glucoside, glycolic acid, fragrance, tetrasodium EDTA, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone.

Properties: Phyto CHX+KET antiseptic shampoo is formulated with chlorhexidine gluconate and ketoconazole, antibacterial and antifungal agents for skin cleansing. This low-lather formula 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: Use 2 to 3 times per week until symptoms subside or as directed by your veterinarian. Wet the animal with cool water from the neck down and apply shampoo first on the areas with skin abnormalities. Starting with a quarter-size amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Leave shampoo on for 10 minutes before rinsing with cool water. For a rinse-free solution between baths, ask your veterinarian about Phyto CHX+KET spray or mousse.

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 Conditions: 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: 11695-7225-8

Phyto CHX+KET

Chlorhexidine gluconate 2%, ketoconazole 1%,

phytosphingosine salicyloyl 0.05%

Antiseptic Shampoo

Antiseptic shampoo for dogs, cats and horses

For animal use only

Keep out of reach of children

Net contents: 8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

covetrus

NDC: 11695-7225-6

Phyto CHX+KET

Chlorhexidine gluconate 2%, ketoconazole 1%,

phytosphingosine salicyloyl 0.05%

Antiseptic Shampoo

Antiseptic shampoo for dogs, cats and horses

For animal use only

Keep out of reach of children

Net contents: 16 fl oz (473 mL)

PRINCIPAL DISPLAY PANEL - 1 Gallon Jug

covetrus

NDC: 11695-7225-1

Phyto CHX+KET

Chlorhexidine gluconate 2%, ketoconazole 1%,

phytosphingosine salicyloyl 0.05%

Antiseptic Shampoo

Antiseptic shampoo for dogs, cats and horses

For animal use only

Keep out of reach of children

Net contents: 1 gallon (3.785 L)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-7225
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	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCOLIC ACID (UNII: 0WT12SX38S)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7225-8	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-7225-6	473 mL in 1 BOTTLE, PLASTIC
3	NDC: 11695-7225-1	3785 mL in 1 JUG

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)