OTICETIC FLUSH, MEDICATED- hydrocortisone and ketoconazole solution

Oticetic Flush, Medicated by

Drug Labeling and Warnings

Oticetic Flush, Medicated by is a Animal medication manufactured, distributed, or labeled by GlenHaven LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

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.

ACTIVE INGREDIENT

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

DESCRIPTION

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

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

WARNING: Keep out of reach of children.

SAFE HANDLING WARNING

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

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

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)

INGREDIENTS AND APPEARANCE

OTICETIC FLUSH, MEDICATED 
hydrocortisone and ketoconazole solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 70782-143
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	10 mg  in 1 mL
Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I)	Ketoconazole	1.5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70782-143-08	236 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/01/2023

Labeler - GlenHaven LLC (002542300)