Label: IXOBA M- moxifloxacin 0.5%, ketorolac 0.5%, prednisolone acetate 1% kit

  • NDC Code(s): 73614-454-03
  • Packager: Brisk Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated November 3, 2021

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  • DESCRIPTION

    Rx Only

    NDC 73614-454-03

    For Use in Eyes Only

    IXOBA M

    Each Pack Contains:

    Moxifloxacin 0.5% Ophthalmic Solution - 3ml

    Ketorolac 0.5% Ophthalmic Solution - 5ml

    Prednisolone Acetate 1% Ophthalmic Suspension - 5ml

    Brisk Pharmaceuticals

  • DESCRIPTION

    See Instructions on the bottom of the package

    What is Ixoba M used for: Ixoba M is a convenient pack containing 3 ophthalmic medication bottles.

    How Supplied: Ixoba M is supplied as a co-pack containing Moxifloxacin 0.5% Ophthalmic Suspension 3ml bottle, Ketorolac 0.5% Ophthalmic Suspension 5ml bottle, Prednisolone Acetate 1% Ophthalmic Suspen-sion 5ml bottle.

    Storage: Store at 20C to 25C (68F-77F). Protect from light.

    Please read the leaflet inside each bottle for ‘full prescribing information’ about that medication.

    Patient Counseling Information:

    Risk of Contamination: Do not touch the dropper tip to any surface to avoid contaminating the contents by common bacteria known to cause ocular infections.

    Concomitant Use of Contact Lenses: Do not administer Moxifloxacin Ophthalmic Suspension, Ketorolac Ophthalmic Suspension or Prednisolone Acetate Ophthalmic Suspension while wearing contact lenses.

    Concomitant Topical Ocular Therapy: If more than one topical ophthalmic medication is being used, the medications should be administered at least 5 minutes apart.

    For questions on Ixoba M, please call your Ophthalmologist Office or Ixoba Assist at 469-342-1471.

  • DESCRIPTION

    Keep out of the reach of children.

    TAMPER EVIDENT: Do not use the individual eye drops inside the pack if the seal on its carton is broken or missing.

    Lot: See the lot number on each individual bottle inside the pack.

    Exp: See the expiration date on each individual bottle inside the pack.

    Packaged By: Unit Dose Solutions Inc., Morrisville, NC 27560

    Packaged for: Brisk Pharmaceuticals, Dallas, TX 75217

  • PATIENT MEDICATION INFORMATION

    front

    back

  • PRINCIPAL DISPLAY PANEL

    IXOBA M box

  • INGREDIENTS AND APPEARANCE
    IXOBA M 
    moxifloxacin 0.5%, ketorolac 0.5%, prednisolone acetate 1% kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:73614-454
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73614-454-031 in 1 CARTON; Type 1: Convenience Kit of Co-Package08/26/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 5 mL
    Part 21 BOTTLE 5 mL
    Part 31 BOTTLE 3 mL
    Part 1 of 3
    KETOROLAC TROMETHAMINE 
    ketorolac tromethamine solution
    Product Information
    Item Code (Source)NDC:61314-126
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L) KETOROLAC5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07658311/05/2009
    Part 2 of 3
    PREDNISOLONE ACETATE 
    prednisolone acetate suspension/ drops
    Product Information
    Item Code (Source)NDC:60758-119
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM) PREDNISOLONE ACETATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BISULFITE (UNII: TZX5469Z6I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA01701108/19/1997
    Part 3 of 3
    MOXIFLOXACIN 
    moxifloxacin solution/ drops
    Product Information
    Item Code (Source)NDC:68180-422
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE (UNII: B8956S8609) (MOXIFLOXACIN - UNII:U188XYD42P) MOXIFLOXACIN5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (Yellow Colored Transparent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    13 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20286707/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/26/2021
    Labeler - Brisk Pharmaceuticals, Inc. (117250794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unit Dose Solutions, Inc360804194repack(73614-454)