FDA.reportPublic FDA data

JEFFERS EAR FLUSH - ADVANCED OTIC CLEANSER

Manufacturer
JEFFERS | COSCO INTERNATIONAL, INC
Effective date
2025-04-01
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:44:29

Label at a glance#

ProductJEFFERS EAR FLUSH - ADVANCED OTIC CLEANSER
Active ingredientKETOCONAZOLE
Label structure8 sections

Dosage and administration

FOR USE ON EARS - Apply solution to the ear canal and with rm but gentle pressure, massage the base of the ear. Use an absorbent material to clean any 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.

Storage and handling

Store at room temperature - 68F to 77F (20°C-25°C). Protect from freezing or excessive heat.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Ketoconazole.......0.2% (Antifungal)

INDICATIONS:

OTC - PURPOSE SECTION

Medicated cleansing and flushing solution to support topical conditions responsive to Ketoconazole.

WARNINGS:

WARNINGS SECTION

For external use only. Not for human use. KEEP OUT OF REACH OF CHILDREN. When using this product, avoid contact with eyes and mucous membranes. If condition worsens, or irritation occurs, stop use and ask your veterinarian.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

FOR USE ON EARS - Apply solution to the ear canal and with rm but gentle pressure, massage the base of the ear. Use an absorbent material to clean any 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.

STORAGE:

STORAGE AND HANDLING SECTION

Store at room temperature - 68F to 77F (20°C-25°C). Protect from freezing or excessive heat.

FIRST AID:

OTHER SAFETY INFORMATION

If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use, and if irritation persists, contact a veterinarian.
If large quantities of this material are swallowed, contact the poison control center immediately!

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water, Polysorbate 20, Propylene Glycol, Aloe Barbadensis Leaf Juice, Ethoxydiglycol, Glycerin, Lactic Acid, Benzyl Alcohol, Boric Acid,
Calendula Ocinalis, Sodium Hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8 fl. oz. Label8 fl. oz. Label8 fl. oz. Label8 fl. oz. Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2609847ketoconazole 0.2 % Otic SolutionPSN1
2609847ketoconazole 2 MG/ML Otic SolutionSCD1
2609847ketoconazole 0.2 % Otic SolutionSY1

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86010-300-01JEFFERS EAR FLUSH - ADVANCED OTIC CLEANSER237 g in 1 BOTTLE, DISPENSINGLIQUID2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86010-300JEFFERS EAR FLUSH - ADVANCED OTIC CLEANSER (KETOCONAZOLE 0.2% MEDICATED OTIC SOLUTION) LIQUID [JEFFERS]11 package rows20250402_2f4bc2ce-8092-4913-94fd-9df1a8c92b0c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86010-30086010-300-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
KETOCONAZOLER9400W927IACTIB
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
ETHOXYDIGLYCOLA1A1I8X02BIACT
GLYCERINPDC6A3C0OXIACT
LACTIC ACID33X04XA5ATIACT
BENZYL ALCOHOLLKG8494WBHIACT
CALENDULA OFFICINALIS WHOLEPFR03EBU0HIACT
SODIUM HYDROXIDE55X04QC32IIACT

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.