FDA.reportPublic FDA data

Oticetic Flush, Medicated

Manufacturer
GlenHaven LLC
Effective date
2023-06-08
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:42:04

Label at a glance#

ProductOticetic Flush, Medicated
Active ingredientHydrocortisone, Ketoconazole
Label structure9 sections

Storage and handling

STORAGE: Store at room temperature.

Label contents#

Full prescribing information#

VETERINARY INDICATIONS SECTION

Oticetic Flush, Medicated is an ear cleanser and drying agent for dogs and cats with conditions responsive to hydrocortisone and ketoconazole. Ceramides aid in moisturizing, repairing, and restoring dry, damaged skin.

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: 1% Hydrocortisone, USP; 0.15% Ketoconazole, USP

DESCRIPTION SECTION

ALSO CONTAINS: Propylene Glycol, SDA 40B Ethanol, Glycerin, Polysorbate 20, Acetic Acid, Ceramide Complex (Ceramide 3, Ceramide 6 II, Ceramide I, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum)

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Apply to ear and gently, but firmly, massage the base of the ear. Use a cotton ball to remove excess solution. Repeat as necessary or as directed by your veterinarian. Close cap tightly.

WARNINGS SECTION

WARNING: Keep out of reach of children.

SAFE HANDLING WARNING SECTION

CAUTION: For topical use only. Avoid contact with eyes. If skin irritation develops or increases, stop use and call your veterinarian. Keep out of the reach of children and pets. Wash hands after use.

STORAGE AND HANDLING SECTION

STORAGE: Store at room temperature.

SPL UNCLASSIFIED SECTION

For Veterinary Use Only.

Manufactured for:
GlenHaven
18101 SE 6th Way
Vancouver, WA 98683

39598 OCFM REV01/23

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GlenHaven®
Therapeutics

FRAGRANCE FREE

Oticetic Flush,
Medicated

Anti-inflammatory,
antimicrobial

Acetic acid,
hydrocortisone &
ketoconazole

For Dog and Cat Use Only

Net Contents: 8 FL OZ. (236 mL)

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2639745hydrocortisone 1 % / ketoconazole 0.15 % Otic SolutionPSN1
2639745hydrocortisone 10 MG/ML / ketoconazole 1.5 MG/ML Otic SolutionSCD1
2639745hydrocortisone 1 % / ketoconazole 0.15 % Otic SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70782-143-08Oticetic Flush, Medicated236 mL in 1 BOTTLESOLUTION2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70782-143OTICETIC FLUSH, MEDICATED (HYDROCORTISONE AND KETOCONAZOLE) SOLUTION [GLENHAVEN LLC]11 package rows20230610_afbf58da-5683-40f1-bb5c-5cb8bfd8251a.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70782-14370782-143-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
HydrocortisoneWI4X0X7BPJACTIB
KetoconazoleR9400W927IACTIB

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 19 · 368 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsName fallback
generic name: HYDROCORTISONE
Terramed Just Think Comfort Hydrocortisone 1% CreamHYDROCORTISONERida LLC0d2c0c2c-370f-4adb-b0ea-1e218c927f8b2026-09-01WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEAmerican Health Packaging506aab0d-9308-4d60-90b3-7d64952fff362026-08-31Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive SkinHYDROCORTISONEAmerisourceBergenc5c5b5ca-b4d4-4fa8-b647-b3ccb29664952026-08-30WarningsName fallback
generic name: HYDROCORTISONE
Gembooxt ECZEMA RELIEF CreamHYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.46490d65-f789-eaa2-e063-6294a90a623b2026-08-27WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEAmazon.com Services LLC5f87d7fb-f258-48b0-8b60-1055e22ebd712026-08-25WarningsName fallback
generic name: HYDROCORTISONE
ANTI ITCHHYDROCORTISONEHyVee Inc1ab6bbb8-2b91-4c53-9168-b1e85ac296e92026-08-19WarningsName fallback
generic name: HYDROCORTISONE
hydrocortisone 1HYDROCORTISONEKroger Companyf05edff2-2dc5-427c-b52c-518e0aaef4e02026-08-19WarningsName fallback
generic name: HYDROCORTISONE
MedPrideHYDROCORTISONEShield Line LLC2f15d3b3-d1e6-4742-9eac-f956c0ffbba42026-08-18WarningsName fallback
generic name: HYDROCORTISONE
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsName fallback
generic name: HYDROCORTISONE
HYDROCORTISONEHYDROCORTISONEAmazon.com Services LLCf40b4223-e81f-4cd0-bc9b-d3d33ce8cce52026-08-12WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONESolco Healthcare LLC04f112e5-ec88-46c8-b675-8b4e38a86ab42026-08-11Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
Hydrocortisone with AloeHYDROCORTISONETARGET Corporation4a140b9a-0e3c-4b50-b9c0-9e72616bb7d52026-08-11WarningsName fallback
generic name: HYDROCORTISONE
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsName fallback
generic name: HYDROCORTISONE
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack484fe5e4-a058-49c0-a382-c8fc3e20c3b22026-08-04WarningsName fallback
generic name: HYDROCORTISONE
HydrocortisoneHYDROCORTISONEREMEDYREPACK INC.f0e66726-946b-4f63-b457-2851dc69e6b42026-08-03Adverse reactionsName fallback
generic name: HYDROCORTISONE
Cortizone 10 Itch Relief Massaging RollerballHYDROCORTISONEChattem, Inc.1e27682c-f856-41f1-9935-37540960a4c72026-07-31WarningsName fallback
generic name: HYDROCORTISONE
hydrocortisoneHYDROCORTISONEEywa Pharma Incb3f06d10-2f01-428c-88a4-505c61c87ce82026-07-25Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsName fallback
generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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