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.

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IXOBA M

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

front

back

IXOBA M box

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)

Revised: 11/2021
Document Id: cfe34a13-de19-4e73-e053-2a95a90a0908
Set id: ca7a8de8-9185-e89f-e053-2995a90a5e04
Version: 2
Effective Time: 20211103
 
Brisk Pharmaceuticals, Inc.