IXOBA M

IXOBA M- moxifloxacin 0.5%, ketorolac 0.5%, prednisolone acetate 1%
Brisk Pharmaceuticals, 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.

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

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.

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

IXOBA M moxifloxacin 0.5%, ketorolac 0.5%, prednisolone acetate 1% kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73614-454

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73614-454-03 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 5 mL Part 2 1 BOTTLE 5 mL Part 3 1 BOTTLE 3 mL

Part 1 of 3 KETOROLAC TROMETHAMINE ketorolac tromethamine solution

Product Information Item Code (Source) NDC:61314-126 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOROLAC TROMETHAMINE (KETOROLAC) KETOROLAC 5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER EDETATE DISODIUM SODIUM CHLORIDE HYDROCHLORIC ACID BENZALKONIUM CHLORIDE SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 5 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076583 11/05/2009

Part 2 of 3 PREDNISOLONE ACETATE prednisolone acetate suspension/ drops

Product Information Item Code (Source) NDC:60758-119 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PREDNISOLONE ACETATE (PREDNISOLONE) PREDNISOLONE ACETATE 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 SODIUM CITRATE EDETATE DISODIUM WATER SODIUM BISULFITE SODIUM CHLORIDE BENZALKONIUM CHLORIDE BORIC ACID HYPROMELLOSES

Packaging # Item Code Package Description Multilevel Packaging 1 1 BOTTLE in 1 CARTON contains a BOTTLE 1 5 mL in 1 BOTTLE This package is contained within the CARTON

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA017011 08/19/1997

Part 3 of 3 MOXIFLOXACIN moxifloxacin solution/ drops

Product Information Item Code (Source) NDC:68180-422 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE (MOXIFLOXACIN) MOXIFLOXACIN 5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BORIC ACID HYDROCHLORIC ACID SODIUM CHLORIDE SODIUM HYDROXIDE WATER

Product Characteristics Color yellow (Yellow Colored Transparent) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 1 BOTTLE in 1 CARTON contains a BOTTLE 1 3 mL in 1 BOTTLE This package is contained within the CARTON

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202867 07/01/2017

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/26/2021

Labeler — Brisk Pharmaceuticals, Inc. (117250794)

Establishment
Name	Address	ID/FEI	Operations
Unit Dose Solutions, Inc		360804194	repack (73614-454)

Revised: 11/2021 Brisk Pharmaceuticals, Inc.