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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

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)