FORTICEPT ANTISEPTIC EAR FLUSH- ketoconazole liquid 
Lidan, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Forticept Antiseptic Ear Flush - Medicated Otic Cleanser

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, Fragrance

8 fl. oz. Label

8 fl. oz. Label

FORTICEPT ANTISEPTIC EAR FLUSH 
ketoconazole liquid
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:72127-0904
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE2 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72127-0904-1237 g in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/18/2022
Labeler - Lidan, Inc. (014456716)
Registrant - Lidan, Inc. (014456716)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture, api manufacture, analysis, pack

Revised: 8/2022
Document Id: 0fb2dffe-a6e6-43fc-b19e-1fcd08be9c10
Set id: 55dedc07-3305-46ed-a3ce-ce6ac5f87a0a
Version: 1
Effective Time: 20220818
 
Lidan, Inc.