FDA.reportPublic FDA data

Truseb Ketoconazole Tris Ear Flush for Dogs, Cats & Horses

Manufacturer
Pet Health Pharma, LLC
Effective date
2026-05-28
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:05

Label at a glance#

ProductTruseb Ketoconazole Tris Ear Flush for Dogs, Cats and Horses
Active ingredientKETOCONAZOLE
Label structure8 sections

Storage and handling

Storage: Store at controlled room temperature

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

WARNINGS AND PRECAUTIONS SECTION

Ketoconazole 0.1%

INDICATIONS & USAGE:

WARNINGS AND PRECAUTIONS SECTION

Truseb™ tris ear flush is pleasantly scented with a refreshing cucumber melon fragrance for general cleansing, flushing and soothing formulation designed for dogs, cats & horses.

INACTIVE INGREDIENT:

WARNINGS AND PRECAUTIONS SECTION

Water, SD Alcohol 40-B, Nonoxynol-9, Disodium EDTA, Benzyl Alcohol, Fragrance, Tromethamine.

DOSAGE & ADMINISTRATION:

WARNINGS AND PRECAUTIONS SECTION

Directions for use: Shake well before use. Apply liberally to the affected area(s). Apply twice daily or as directed by veterinarian. Use cotton or absorbent material to clean excess solution and wipe away debris. Do not allow the animal to lick the treated area until dry to prevent ingestion. Wash hands after use.

PRECAUTIONS:

WARNINGS AND PRECAUTIONS SECTION

Cautions: For animal use only. For topical use only. Avoid contact with eyes or mucous membranes. If undue skin irritation develops or increases, discontinue use and consult your veterinarian. In case of contact, flush eyes with water and seek medical attention if undue irritation persists. Keep out of the reach of children.

STORAGE AND HANDLING:

WARNINGS AND PRECAUTIONS SECTION

Storage: Store at controlled room temperature

SPL UNCLASSIFIED SECTION:

SPL UNCLASSIFIED SECTION

• Otic

• Cleaning

• Deodorizing

• Soothing

Antiseptic Tris Ear Flush

SOLUTION FOR CLEANSING & FLUSHING OF EARS AND SKIN

FOR DOGS & CATS

ANTIMICROBIAL

CUCUMBER MELON SCENT

MADE IN THE USA

ADVANCED VETERINARY FORMULA
Broad Spectrum

Distributed by:
Pet Health Pharma, Inc
7726 N Frst St, Suite 272
Fresno , CA 93720
(1)-559-900-7038
pethealthpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRIS FLUSH- 4TRIS FLUSH- 4

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TRIS FLUSH- 8TRIS FLUSH- 8

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TRIS FLUSH- 12TRIS FLUSH- 12

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1297960ketoconazole 0.1 % Topical SolutionPSN1
1297960ketoconazole 1 MG/ML Topical SolutionSCD1
1297960ketoconazole 0.1 % Topical SolutionSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860173001989GTIN-13: 0860173001989
EAN-13: 0860173001989
GTIN-12: 860173001989
UPC-A: 860173001989
GTIN storage (14 digits): 00860173001989		TRIS FLUSH- 4 oz.jpg, TRIS FLUSH- 12 oz.jpg, TRIS FLUSH- 8 oz.jpg

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86176-108-04Truseb Ketoconazole Tris Ear Flush for Dogs, Cats and Horses118 mL in 1 BOTTLE, PLASTICSOLUTION1181
86176-108-08Truseb Ketoconazole Tris Ear Flush for Dogs, Cats and Horses237 mL in 1 BOTTLE, PLASTICSOLUTION2371
86176-108-12Truseb Ketoconazole Tris Ear Flush for Dogs, Cats and Horses355 mL in 1 BOTTLE, PLASTICSOLUTION3551

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86176-10886176-108-04, 86176-108-08, 86176-108-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
KETOCONAZOLER9400W927IACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
NONOXYNOL-948Q180SH9TIACT
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
TROMETHAMINE023C2WHX2VIACT

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 · 56 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
KETOCONAZOLEKETOCONAZOLEPD-Rx Pharmaceuticals, Inc.f162e616-21b4-49b1-b437-15e21001a6f02026-07-07Boxed warning, Warnings, Adverse reactionsName 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
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
KetoconazoleKETOCONAZOLEGolden State Medical Supply, Inc.a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b72025-11-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: KETOCONAZOLE
ketoconazoleKETOCONAZOLEBryant Ranch Prepacka878a39d-6d26-4ede-9667-b3e201ffc3372025-10-24Warnings, Adverse reactionsName fallback
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEBryant Ranch Prepack6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf2025-10-24Adverse reactionsName fallback
generic name: KETOCONAZOLE

Reported adverse events (FAERS/openFDA)#

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