FDA.reportPublic FDA data

Nootie Medicated Pet Ear Flush

Manufacturer
Nootie LLC
Effective date
2022-11-24
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:41:42

Label at a glance#

ProductNootie Medicated Pet Ear Flush
Active ingredientCHLORHEXIDINE GLUCONATE, KETOCONAZOLE
Label structure8 sections

Indications and uses

For topical skin conditions responsive to Chlorhexidine Gluconate and Ketoconazole.

Dosage and administration

For use on ears, apply solution to the ear canal and with firm but gentle pressure, massage the base of the ear. Use an absorbent material to clean any excess solution. For topical skin use , apply solution to the affected area and use a cotton ball to absorb any excess solution. Wash hands after application. Use once daily or as directed by your veterinarian.

Storage and handling

Store at room temperature (60 - 80°F). Protect from high temperatures. Protect from freezing.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine Gluconate 0.2%
Ketoconazole 0.2%

Other Ingredients:

INACTIVE INGREDIENT SECTION

Purified Water, Propylene Glycol, Nonoxynol-12, Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Polysorbate 20, Fragrance, Lactic Acid, Benzyl Alcohol.

Uses:

INDICATIONS & USAGE SECTION

For topical skin conditions responsive to Chlorhexidine Gluconate and Ketoconazole.

Warnings:

WARNINGS SECTION

› For animal use only.
› For topical use on dogs and cats.
› Avoid contact with eyes and mucous membranes.
› If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use and immediately consult your veterinarian.
› Keep out of reach of children.

Directions:

DOSAGE & ADMINISTRATION SECTION

For use on ears, apply solution to the ear canal and with firm but gentle pressure, massage the base of the ear. Use an absorbent material to clean any excess solution. For topical skin use, apply solution to the affected area and use a cotton ball to absorb any excess solution. Wash hands after application. Use once daily or as directed by your veterinarian.

Storage:

STORAGE AND HANDLING SECTION

Store at room temperature (60 - 80°F). Protect from high temperatures. Protect from freezing.

SPL UNCLASSIFIED SECTION

Nootie™ DERMATOLOGY SOLUTIONS

TOPICAL EAR & SKIN TREATMENT

HELPS TREAT AND RELIEVE:

› Hot Spots
› Ringworm
› Allergic Dermatitis
› Topical Ear & Skin Conditions

FOR DOGS AND CATS

√ Formulated with veterinarian strength active ingredients.
√ Helps treat and manage ear and skin conditions responsive to Chlorhexidine and Ketoconazole.

MADE IN USA

Manufactured for and distributed by
Nootie LLC, 6421 Congress Ave., Suite 121
Boca Raton, FL 33487 1-800-478-7713
Nootie.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nootie-109Nootie-109

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1797506chlorhexidine gluconate 2 MG/ML / ketoconazole 2 MG/ML Topical SolutionSCD2
1797506chlorhexidine gluconate 0.2 % / ketoconazole 0.2 % Topical SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
KETOCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51437-109-04Nootie Medicated Pet Ear Flush118 mL in 1 BOTTLESOLUTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51437-109NOOTIE MEDICATED PET EAR FLUSH (CHLORHEXIDINE GLUCONATE, KETOCONAZOLE) SOLUTION [NOOTIE LLC]21 package rows20221208_99ea94ef-6f2e-4021-a629-dbd482e1f5a3.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
51437-10951437-109-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB
KETOCONAZOLER9400W927IACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
NONOXYNOL-126NR43D77O6IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYSORBATE 207T1F30V5YHIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
BENZYL ALCOHOLLKG8494WBHIACT

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 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATEPAI Holdings, LLC dba PAI Pharmad3c2d8a7-bad5-410f-af83-e78a45e4b93f2026-08-25Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEMedline Industries, LP92eddf00-7e23-4d5b-b5cd-38af99ad9e562026-08-19Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE GLUCONATECHLORHEXIDINE GLUCONATESage Products LLCbdb6a012-37e5-4664-84a3-134bea2847442026-06-16WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Sponge with 4% w/w chlorhexidine gluconate (CHG)CHLORHEXIDINE GLUCONATEXinxiang Xinda Technology Co.,Ltd53f4dd22-e4ab-5d8a-e063-6294a90a8c392026-06-11WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Swab Applicator Brushes 4% w/w chlorhexidine gluconate (CHG)CHLORHEXIDINE GLUCONATEXINXIANG XINDA TECHNOLOGY CO.,LTD51c1a74f-c6a8-b831-e063-6294a90a6c712026-05-24WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Swab Stick 2% w/w chlorhexidine gluconate (CHG)CHLORHEXIDINE GLUCONATEXINXIANG XINDA TECHNOLOGY CO.,LTD51c5a926-d137-9119-e063-6294a90a88452026-05-24WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Dyna-Hex 4CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.0a32c299-f7ca-d15c-e063-6294a90af2c12026-04-30WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEMajor Pharmaceuticalsb48e69dc-0913-423f-e053-2a95a90a53df2026-04-29Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEBenco Dental21b03b2a-44ee-41c0-e054-00144ff8d46c2026-04-29Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Bactoshield CHGCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a6403ad-fa5e-2b4a-e054-00144ff8d46c2026-04-28WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3a4cfe-88e0-0a10-e054-00144ff88e882026-04-27Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a9eda34-d85c-4b66-e054-00144ff88e882026-04-27WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.4a3a684f-5f72-347a-e054-00144ff8d46c2026-04-27Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
DYNA-HEX 2CHLORHEXIDINE GLUCONATEXttrium Laboratories, Inc.6cc89ac1-baef-40bb-85a3-d9ae9e3e7a632026-04-27WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Chlorhexidine GluconateCHLORHEXIDINE GLUCONATEPreferred Pharmaceuticals, Inc.1c3401ef-6a7a-485e-ab7e-52420a36f4e22026-03-27Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
CleanCare Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESafco Dental Supply LLC0d950be9-9d25-202c-e063-6294a90ada7d2026-03-02Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
CleanCare Chlorhexidine Gluconate 0.12% Oral RinseCHLORHEXIDINE GLUCONATESafco Dental Supply LLC0d9624f6-2a0b-c30f-e063-6294a90ae7172026-03-02Warnings, Adverse reactionsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0b50ef-78e1-5595-e063-6294a90aa84d2026-02-17WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0c6bcd-2242-f734-e063-6294a90a8fbf2026-02-17WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE
Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%CHLORHEXIDINE GLUCONATEHenry Schein, Inc.4b0d7b42-5757-6248-e063-6394a90a94c52026-02-17WarningsName fallback
generic name: CHLORHEXIDINE GLUCONATE

Reported adverse events (FAERS/openFDA)#

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