CERASOOTHE CHX PLUS KET- chlorhexidine gluconate, ketoconazole shampoo

CeraSoothe by

Drug Labeling and Warnings

CeraSoothe 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

CeraSoothe CHX+KET

Antiseptic Shampoo

Fragrance: Cucumber melon

Formulated for cats, dogs and horses

Keep out of reach of children

For animal use only

A shampoo with chlorhexidine and ketoconazole, antibacterial and antifungal ingredients for antiseptic skin cleansing. Ceramides and avenanthramides are skin nourishing nutrients that moisturize and calm the skin. They also support the skin’s natural immune system and provide building blocks for renewed skin barrier integrity.

Active ingredients: Chlorhexidine gluconate 2%, ketoconazole 1%.

Inactive ingredients: Water, lauramine oxide, cocamidopropyl betaine, polyacrylate-1 crosspolymer, decyl glucoside, glycolic acid, avena sativa (oat) kernel extract, glycerin, ceramide EOP, ceramide EOS, ceramide NP, potassium sorbate, fragrance, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone.

INDICATIONS & USAGE

Indications: For use on cats, dogs, and horses with bacterial or fungal skin infections that are responsive to chlorhexidine gluconate and ketoconazole.

Directions for use: Bathe 2-3 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 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. Wash hands after use. For a rinse-free solution between baths, use CeraSoothe CHX+KET antiseptic mousse, wipes, and/or spray.

WARNINGS AND PRECAUTIONS

Cautions: For use on cats, dogs and horses only. Avoid contact with eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult your veterinarian.

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

Inspired by veterinarians

CeraSoothe CHX+KET

Antiseptic Shampoo

Fragrance: Cucumber melon

Chlorhexidine gluconate 2%

Ketoconazole 1%

Formulated for cats, dogs and horses

Keep out of reach of children

For animal use only

NDC: 11695-6973-1

Net contents: 8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

Inspired by veterinarians

CeraSoothe CHX+KET

Antiseptic Shampoo

Fragrance: Cucumber melon

Chlorhexidine gluconate 2%

Ketoconazole 1%

Formulated for cats, dogs and horses

Keep out of reach of children

For animal use only

NDC: 11695-6973-2

Net contents: 16 fl oz (473 mL)

PRINCIPAL DISPLAY PANEL - 1 Gallon (3.785L) Jug

Inspired by veterinarians

CeraSoothe CHX+KET

Antiseptic Shampoo

Fragrance: Cucumber melon

Chlorhexidine gluconate 2%

Ketoconazole 1%

Formulated for cats, dogs and horses

Keep out of reach of children

For animal use only

NDC: 11695-6973-3

Net contents: 1 gallon (3.785L)

INGREDIENTS AND APPEARANCE

CERASOOTHE  CHX PLUS KET
chlorhexidine gluconate, ketoconazole shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-6973
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCOLIC ACID (UNII: 0WT12SX38S)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
GLYCERIN (UNII: PDC6A3C0OX)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-6973-1	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-6973-2	473 mL in 1 BOTTLE, PLASTIC
3	NDC: 11695-6973-3	3785 mL in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/09/2021

Labeler - BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA (603750329)

Registrant - Ceva Sante Animale (261126049)