CERASOOTHE KET- ketoconazole solution

Ceraven by

Drug Labeling and Warnings

Ceraven 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 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 & USAGE

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.

PRECAUTIONS

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 AND HANDLING

Storage: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

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)

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)

INGREDIENTS AND APPEARANCE

CERASOOTHE  KET
ketoconazole solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-6979
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-6979-1	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-6979-2	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/02/2021

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

Registrant - Ceva Sante Animale (261126049)