CeraSoothe

Manufacturer
Butler Animal Health Supply, LLC dba Covetrus North America | Ceva Sante Animale
Effective date
2022-05-23
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:41:26

Label at a glance#

ProductCeraSoothe KET
Active ingredientKETOCONAZOLE
Label structure7 sections

Storage and handling

Storage: Store at room temperature. Do not freeze.

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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 SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 label4 ounce bottle label

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1297960ketoconazole 0.1 % Topical SolutionPSN2
1297960ketoconazole 1 MG/ML Topical SolutionSCD2
1297960ketoconazole 0.1 % Topical SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11695-6979-1CeraSootheKET118 mL in 1 BOTTLE, PLASTICSOLUTION1182
11695-6979-2CeraSootheKET473 mL in 1 BOTTLE, PLASTICSOLUTION4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11695-6979CERASOOTHE KET (KETOCONAZOLE) SOLUTION [BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA]22 package rows20220525_8d38d2e9-0cfe-465c-bb4c-010bbc9be68d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11695-697911695-6979-1, 11695-6979-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTI-DANDRUFFKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.5ac93feb-eb6d-7563-e063-6294a90ad2e02026-09-05WarningsName fallback
generic name: KETOCONAZOLE
KetoconClear CreamKETOCONAZOLEGuangzhou Shunfei Network Technology Co., Ltd.5a54eebe-5b4a-28dd-e063-6294a90a607f2026-08-31WarningsName fallback
generic name: KETOCONAZOLE
Gembooxt Ketoconazole 1% Medicated ShampoosKETOCONAZOLEGuangdong Quadrant Ecological Technology Co., Ltd.49965e91-43c3-65d7-e063-6294a90abaec2026-08-27WarningsName fallback
generic name: KETOCONAZOLE
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.599f2cce-0c27-d425-e063-6394a90a15652026-08-22WarningsName fallback
generic name: KETOCONAZOLE
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.59a0a062-92d1-210a-e063-6394a90a9bf92026-08-22WarningsName fallback
generic name: KETOCONAZOLE
KETOCONAZOLEKETOCONAZOLEAmerisyn LLC1d598696-c6f3-4b7c-ad73-949d2089df352026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: KETOCONAZOLE
Gemachlich ZuHause Ketoconazole 1% Anti-dandruff ShampoosKETOCONAZOLEGuangzhou Xinhongda Trading Service Co., Ltd.5792eff5-632e-3664-e063-6394a90a8ae32026-07-27WarningsName fallback
generic name: KETOCONAZOLE
KETOCONAZOLEKETOCONAZOLEPD-Rx Pharmaceuticals, Inc.f162e616-21b4-49b1-b437-15e21001a6f02026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: KETOCONAZOLE
Cysndra Ketoconazole 1% Medicated ShampoosKETOCONAZOLEGuangzhou Xinhongda Trading Service Co., Ltd.55ee7358-dfc1-b600-e063-6394a90a49d82026-07-06WarningsName fallback
generic name: KETOCONAZOLE
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.4cfe234c-49c0-18e8-e063-6294a90a0b1d2026-07-02WarningsName fallback
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLENuCare Pharmaceuticals, Inc.53492ad1-baca-a7f6-e063-6294a90a29902026-06-02Adverse reactionsName fallback
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEPreferred Pharmaceuticals Inc.d59df5bf-bfa6-45fa-81f6-8c8ee2f24cf82026-05-14Adverse reactionsName fallback
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEANI Pharmaceuticals, Inc.00c1cac8-a865-4583-aaba-3a0f21fb31e62026-01-29Adverse reactionsName fallback
generic name: KETOCONAZOLE
ketoconazoleKETOCONAZOLEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCcad7c647-34a9-4e4e-83b3-8d78e58f588f2026-01-28Warnings, Adverse reactionsName fallback
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLENORTHSTAR RX LLCbf3e48fd-e063-42e6-acd1-580ddc6e93be2026-01-26Warnings, Adverse reactionsName fallback
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLETHIRTY MADISON INC1f5cd9f4-0db4-4062-b5ec-c33611265e022025-12-17Adverse reactionsName fallback
generic name: KETOCONAZOLE
KETOCONAZOLEKETOCONAZOLEStrides Pharma Science Limited6d4be760-c723-4f54-a854-12c61cf917032025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLENuCare Pharmaceuticals,Inc.4578c84a-d438-6740-e063-6294a90a01512025-12-08Adverse reactionsName fallback
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLENorthstar Rx LLCc4f711dc-d0ea-4beb-9a78-b7e3594ee4be2025-12-01Adverse reactionsName fallback
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEBryant Ranch Prepack4baebcab-a237-42c0-9183-6f447a44e3712025-11-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: KETOCONAZOLE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.