FORTICEPT ANTISEPTIC EAR FLUSH- ketoconazole liquid

Forticept Antiseptic Ear Flush by

Drug Labeling and Warnings

Forticept Antiseptic Ear Flush by is a Animal medication manufactured, distributed, or labeled by Lidan, Inc., Cosco International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s):

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.
Stop use and ask a veterinarian if condition worsens, or irritation occurs.

Directions:

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 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 poison control center immediately!

Inactive ingredients:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FORTICEPT ANTISEPTIC EAR FLUSH 
ketoconazole liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 72127-0904
Route of Administration	TOPICAL

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 VERA LEAF (UNII: ZY81Z83H0X)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BORIC ACID (UNII: R57ZHV85D4)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72127-0904-1	237 g in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/18/2022

Labeler - Lidan, Inc. (014456716)

Registrant - Lidan, Inc. (014456716)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture, api manufacture, analysis, pack