CERASOOTHE CHX PLUS KET WIPES- chlorhexidine gluconate, ketoconazole swab

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 WIPES

ACTIVE INGREDIENTS: Chlorhexidine gluconate 2%, Ketoconazole 1%.

INACTIVE INGREDIENTS: Water, glycerin, polysorbate 20, propylene glycol, lactic acid, avena sativa (oat) kernal extract, ceramide EOP, ceramide EOS, ceramide NP, fragrance, potassium sorbate, methylisothiazolinone.

INDICATIONS & USAGE

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

DIRECTIONS FOR USE: Wipe the targeted area 1 to 3 times daily, or use as directed by your veterinarian. Do not allow the animal to lick the treated area. Do not reuse wipes. Wash hands after use.

WARNINGS AND PRECAUTIONS

CAUTIONS: For external 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 with your veterinarian.

WARNING: Keep out of reach of children.

STORAGE AND HANDLING

STORAGE: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

QUESTIONS? 1-800-999-029

PRINCIPAL DISPLAY PANEL - 30 Count Canister

Inspired by veterinarians

CeraSoothe CHX+KET

Antiseptic Wipes

Fragrance: Cucumber melon

Chlorhexidine gluconate 2%

Ketoconazole 1%

Formulated cats, dogs, and horses

Keep out of reach of children

For animal use only

NDC: 11695-6976-1

Net Contents: 30 Wipes

INGREDIENTS AND APPEARANCE

CERASOOTHE  CHX PLUS KET WIPES
chlorhexidine gluconate, ketoconazole swab

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-6976
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
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	10 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LACTIC ACID (UNII: 33X04XA5AT)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-6976-1	30 in 1 CANISTER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/16/2021

Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)

Registrant - Ceva Sante Animale (261126049)