FDA.reportPublic FDA data

ANTIBACTERIAL & ANTIFUNGAL MEDICATED TRIS FLUSH

Manufacturer
Smiling Paws Pets LLC
Effective date
2026-04-28
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:46:54

Label at a glance#

ProductANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH
Active ingredientKETOCONAZOLE
Label structure9 sections

Dosage and administration

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.

Storage and handling

Store at controlled room temperature; protect from freezing.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS
Ketoconazole...............................................0.1%

OTC - PURPOSE SECTION

ANTIBACTERIAL & ANTIFUNGAL MEDICATED TRIS FLUSH For Dogs & Cats

FIGHT FUNGUS!

INDICATIONS & USAGE SECTION

Say goodbye to pesky ear infections. Treatment is as easy as point, squeeze and soothe. Skin conditions that are responsive to Ketoconazole stand no chance against this powerful formula. Non-irritating formula ensures pets are comfortable.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PRECAUTIONS

GENERAL PRECAUTIONS SECTION

For topical use on animals only. Avoid contact with eyes, or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. Do not allow the animal to directly inhale the spray. If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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.

STORAGE

STORAGE AND HANDLING SECTION

Store at controlled room temperature; protect from freezing.

SPL UNCLASSIFIED SECTION

Contains ketoconazole
Manages fungal activity
Gentle flushing of ears & skin
Antiseptic & antifungal solution

GENTLE ON SKIN
CHOSEN BY TOP VETS
FOR DOGS AND CATS

Smiling Paws Pets
5924 Sheridan St
Hollywood, FL 33021
www.smilingpawspets.com

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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

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
86255-004-01ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH1 in 1 CONTAINERSOLUTION11
86255-004-01ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH355 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
86255-00486255-004-01

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
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
BENZYL ALCOHOLLKG8494WBHIACT
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.