JEFFERS EAR FLUSH - ADVANCED OTIC CLEANSER- ketoconazole 0.2% medicated otic solution liquid

JEFFERS EAR FLUSH - ADVANCED OTIC CLEANSER by

Drug Labeling and Warnings

JEFFERS EAR FLUSH - ADVANCED OTIC CLEANSER by is a Animal medication manufactured, distributed, or labeled by JEFFERS, COSCO INTERNATIONAL, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Ketoconazole.......0.2% (Antifungal)

INDICATIONS:

Medicated cleansing and flushing solution to support topical conditions responsive to Ketoconazole.

WARNINGS:

For external use only. Not for human use. KEEP OUT OF REACH OF CHILDREN. When using this product, avoid contact with eyes and mucous membranes. If condition worsens, or irritation occurs, stop use and ask your veterinarian.

DIRECTIONS:

FOR USE ON EARS - Apply solution to the ear canal and with rm but gentle pressure, massage the base of the ear. Use an absorbent material to clean any 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:

Store at room temperature - 68F to 77F (20°C-25°C). Protect from freezing or excessive heat.

FIRST AID:

If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use, and if irritation persists, contact a veterinarian.
If large quantities of this material are swallowed, contact the poison control center immediately!

INACTIVE INGREDIENTS:

Water, Polysorbate 20, Propylene Glycol, Aloe Barbadensis Leaf Juice, Ethoxydiglycol, Glycerin, Lactic Acid, Benzyl Alcohol, Boric Acid,
Calendula Ocinalis, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JEFFERS EAR FLUSH - ADVANCED OTIC CLEANSER 
ketoconazole 0.2% medicated otic solution liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86010-300
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	2 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86010-300-01	237 g in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2025

Labeler - JEFFERS (094385218)

Registrant - JEFFERS (094385218)

Establishment
Name	Address	ID/FEI	Business Operations
COSCO INTERNATIONAL, INC		016433141	manufacture, api manufacture