CERASOOTHE KET- ketoconazole solution 
Butler Animal Health Supply, LLC dba Covetrus North America

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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CeraSoothe KET

Antiseptic Flush

Fragrance free

Ketoconazole 0.1%

Formulated for cats and dogs

Keep out of reach of children

For animal use only

A gentle antifungal and antibacterial skin and ear cleansing solution. Ketoconazole fights yeast and fungi. Tromethamine (TRIS) helps break down bacteria cell walls. 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: Ketoconazole 0.1%.

Inactive ingredients: Water, SD Alcohol 40-B, nonoxynol-9, disodium EDTA, tromethamine, avena sativa (oat) kernal extract, glycerin, ceramide EOP, ceramide EOS, ceramide NP, potassium sorbate, methylisothiazolinone.

Indications: For use on cats and dogs for the antiseptic cleansing of skin and ears.

Directions for use: Apply twice a day or as directed by your veterinarian. Wash hands after use.

Ear cleaning: Moisten a cotton ball with solution and place in entrance of ear canal, or hold the ear flap upwards and fill the ear canal with solution. Then, gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away debris and excess solution with a clean, dry cotton ball.

Skin cleaning: Moisten absorbent material with solution and gently wipe the area to clean and remove debris. Repeat as necessary until clean.

Cautions: For external use on dogs or cats 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: Store at room temperature. Do not freeze.

Questions?

(855) 724-3461

Distributed by:
Covetrus North America
Dublin, OH 43017
covetrus.com

PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle

Inspired by veterinarians

CeraSoothe KET

Antiseptic Flush

Fragrance free

Ketoconazole 0.1%, 

Formulated for cats and dogs

Keep out of reach of children

For animal use only

NDC 11695-6979-1

Net contents: 4 fl oz (118 mL)

4 ounce bottle label

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

Inspired by veterinarians

CeraSoothe KET

Antiseptic Flush

Fragrance free

Ketoconazole 0.1%,

Formulated for cats and dogs

Keep out of reach of children

For animal use only

NDC 11695-6979-2

Net contents: 16 fl oz (473 mL)

image description

CERASOOTHE  KET
ketoconazole solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-6979
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROMETHAMINE (UNII: 023C2WHX2V)  
AVENANTHRAMIDES (UNII: 5PA41O4AIT)  
GLYCERIN (UNII: PDC6A3C0OX)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
CERAMIDE EOS (UNII: CR0J8RN66K)  
CERAMIDE NP (UNII: 4370DF050B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-6979-1118 mL in 1 BOTTLE, PLASTIC
2NDC:11695-6979-2473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/02/2021
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 5/2022
Document Id: 6d26b02f-cec4-4594-8ca1-f0468ab0829e
Set id: 8d38d2e9-0cfe-465c-bb4c-010bbc9be68d
Version: 2
Effective Time: 20220523
 
Butler Animal Health Supply, LLC dba Covetrus North America