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, Dechra Veterinary Products. 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 inflamed and infected ears due to bacteria and/or fungi (yeast). Ceramides aid in moisturizing, repairing, and restoring dry, damaged skin.

DESCRIPTION

CONTAINS: 2% boric acid, 1% acetic acid, 1% hydrocortisone, 0.15% ketoconazole, propylene glycol, ceramides, glycerin, polysorbate, triethanolamine, fragrance.

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 controlled room temperature of 59°-86° F (15°- 30° C).

SPL UNCLASSIFIED SECTION

Available through licensed veterinarians only.

Manufactured for:

GlenHaven
PO Box 13998
8000 NE Tillamook St.
Portland, OR 97213

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

GlenHaven™
Therapeutics

Medically Formulated

Oticetic Flush,
Medicated

New Improved Formulation
Formerly F2/0

Anti-inflammatory,
antimicrobial

Acetic acid, boric 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: 70782-142
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
Propylene Glycol (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
BORIC ACID (UNII: R57ZHV85D4)
ACETIC ACID (UNII: Q40Q9N063P)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CETEARETH-12 (UNII: 7V4MR24V5P)
Phytosphingosine (UNII: GIN46U9Q2Q)
Cholesterol (UNII: 97C5T2UQ7J)
Sodium Lauroyl Lactylate (UNII: 7243K85WFO)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
Xanthan Gum (UNII: TTV12P4NEE)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70782-142-08	236 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		06/01/2016

Labeler - GlenHaven LLC (002542300)

Registrant - Dechra Veterinary Products (362142734)