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

IXOBA M by

Drug Labeling and Warnings

IXOBA M by is a Prescription medication manufactured, distributed, or labeled by Brisk Pharmaceuticals, Inc., Unit Dose Solutions, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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	Marketing Start Date	Marketing End Date
1	NDC: 73614-454-03	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	08/26/2021

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)	KETOROLAC	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		5 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM)	PREDNISOLONE ACETATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		5 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE (UNII: B8956S8609) (MOXIFLOXACIN - UNII:U188XYD42P)	MOXIFLOXACIN	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
1		3 mL in 1 BOTTLE; Type 0: Not a Combination Product

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	Business Operations
Unit Dose Solutions, Inc		360804194	repack(73614-454)