T8 Keto Flush

Manufacturer
Elanco US Inc.
Effective date
2025-10-28
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:46:09

Label at a glance#

ProductT8 Keto Flush
Active ingredientKetoconazole
Label structure8 sections

Dosage and administration

Shake well before use. Apply T8 Keto Flush liberally to affected area(s). Use cotton or absorbent material to clean excess solution and debris. Apply twice daily or as directed by your veterinarian. CAUTIONS: For topical use on dogs, cats and horses. Avoid contact with eyes. If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use and consult your veterinarian. Available thro...

Storage and handling

Store at room temperature. Protect from freezing. Manufactured for Elanco US Inc. Greenfield, IN 46140 DVM & Design, T8 Keto, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2022 Elanco or its affiliates. Patent information at http://www.elancopatents.com 90210013_YL600284A 90210015_YL600284C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

A Topical Formulation with Tris-EDTA for Dogs, Cats & Horses

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

WARNING: Keep out of reach of children. Not For Human Use.

Otic

Net Contents: 118 mL (4 fl oz)

Net Contents: 355 mL (12 fl oz)

KEY INGREDIENTS:

SPL UNCLASSIFIED SECTION

Contains Tris-EDTA and ketoconazole in a proprietary water-based formulation.

PRODUCT DESCRIPTION:

DESCRIPTION SECTION

T8 Keto Flush is a patented, alkaline (pH 8.5), water-based formulation with mild surfactants for gentle cleansing and flushing. It contains ketoconazole, buffered chelating agents, and a preservative.

INDICATIONS:

INDICATIONS & USAGE SECTION

For gentle flushing and cleansing of skin and ears in such conditions as recommended by your veterinarian.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Shake well before use. Apply T8 Keto Flush liberally to affected area(s). Use cotton or absorbent material to clean excess solution and debris. Apply twice daily or as directed by your veterinarian.

CAUTIONS: For topical use on dogs, cats and horses. Avoid contact with eyes. If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use and consult your veterinarian. Available through licensed veterinarians.

STORAGE:

STORAGE AND HANDLING SECTION

Store at room temperature. Protect from freezing.

Manufactured for Elanco US Inc.
Greenfield, IN 46140

DVM & Design, T8 Keto, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2022 Elanco or its affiliates.

Patent information at www.elancopatents.com

90210013_YL600284A
90210015_YL600284C

Principal Display Panel – 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™

T8 KetoTM
FLUSH

A Topical Formulation with Tris-EDTA
for Dogs, Cats & Horses

CAUTION: Federal law restricts this drug to
use by or on the order of a licensed veterinarian.

WARNING: Keep out of reach of
children. Not For Human Use.

Otic

NET CONTENTS 118 mL (4 fl oz)

Principal Display Panel - 118 mL Bottle Label
Principal Display Panel - 118 mL Bottle Label

Principal Display Panel – 355 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™

T8 KetoTM
FLUSH

A Topical Formulation
with Tris-EDTA for
Dogs, Cats & Horses

CAUTION: Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

WARNING: Keep out of reach of
children. Not For Human Use.

Otic

NET CONTENTS 355 mL (12 fl oz)

Principal Display Panel - 355 mL Bottle Label
Principal Display Panel - 355 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1297960ketoconazole 0.1 % Topical SolutionPSN3
1297965T8 Keto Flush 0.1 % Topical SolutionPSN3
1297965ketoconazole 1 MG/ML Topical Solution [T8 Keto Flush]SBD3
1297960ketoconazole 1 MG/ML Topical SolutionSCD3
1297960ketoconazole 0.1 % Topical SolutionSY3
1297965T8 Keto Flush 0.1 % Topical SolutionSY3
1297965T8 Keto Flush 1 MG/ML Topical SolutionSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
58198-0013-1T8 Keto Flush1 in 1 BOTTLE, PLASTICSOLUTION13
58198-0013-1T8 Keto Flush118 mL in 1 BOTTLE, PLASTICSOLUTION1183
58198-0013-2T8 Keto Flush1 in 1 BOTTLE, PLASTICSOLUTION13
58198-0013-2T8 Keto Flush355 mL in 1 BOTTLE, PLASTICSOLUTION3553

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58198-001358198-0013-1, 58198-0013-2

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
KetoconazoleR9400W927IACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22023-04-18full-release2026-06-01 02:41:59

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.