Label: FORTICEPT ANTI-ITCH EAR DROPS- hydrocortisone 1% medicated otic solution liquid

  • Category: OTC ANIMAL DRUG LABEL

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Drug Label Information

Updated August 20, 2022

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  • Active Ingredient(s):

    Hydrocortisone........1% (Anti-Itch)

  • Indications:

    Helps relive itching associated with minor skin irritations, inflammation, and rashes.

  • Warnings:

    For external use only / Not for human use
    Keep out of reach of children - if swallowed, get medical help or contact a Poison Control Center right away.
    When using this product - Avoid contact with eyes
    Stop use and ask a veterinarian if condition worsens, symptoms persist for more than 7 days, or clear up and occur again with a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.

  • Directions:

    Pre-clean ear with Forticept® Antiseptic Ear Flush. Apply solution to the ear canal and with firm but gentle pressure, massage the base of the ear.

  • Storage:

    Store at room temperature. Protect from freezing or excessive heat.

  • Inactive Ingredients:

    Propylene Glycol, Glycerin, Water, Carbamide, Polysorbate 20, Povidone-iodine, Benzyl Alcohol, Boric Acid

  • Questions:

    +1(470) 736-8166

    Lidan, Inc., Kennesaw, GA  30152 USA

    www.forticept.com

  • PRINCIPAL DISPLAY PANEL

    2oz label front

    2oz label back

  • INGREDIENTS AND APPEARANCE
    FORTICEPT ANTI-ITCH EAR DROPS 
    hydrocortisone 1% medicated otic solution liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:72127-0906
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    UREA (UNII: 8W8T17847W)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POVIDONE-IODINE (UNII: 85H0HZU99M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BORIC ACID (UNII: R57ZHV85D4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72127-0906-160 g in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/20/2022
    Labeler - Lidan, Inc. (014456716)
    Registrant - Lidan, Inc. (014456716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture, api manufacture, analysis, pack
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