Label: FORTICEPT ANTISEPTIC EAR FLUSH- ketoconazole liquid

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 18, 2022

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  • 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

  • INGREDIENTS AND APPEARANCE
    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
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