FDA.reportPublic FDA data

Goniotaire

Manufacturer
Altaire Pharmaceuticals Inc.
Effective date
2022-10-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:44:41

Label at a glance#

ProductGoniotaire
Active ingredientHYPROMELLOSE 2906 (4000 MPA.S)
Label structure8 sections

Dosage and administration

Fill gonioscopic prism with solution as necessary.

Storage and handling

Store at room temperature 15°- 30°C (59°- 86°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Altaire

Goniotaire

Hypromellose 2.5% Ophthalmic

Demulcent Solution

 15mL

NDC 59390-182-13

Drug Facts

Each mL Contains:

Active:

SPL UNCLASSIFIED SECTION

Hypromellose 25mg (2.5%):

Inactives:

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride, Boric Acid, Edetate Disodium, Sodium Borate, Water for injection. Hydrochloric Acid and/or sodium hydroxide may be added to adjust pH (6.0 to 7.8).

NOTE: If this solution dries on optical surfaces, let them stand in cool water before cleansing.

INDICATIONS:

INDICATIONS & USAGE SECTION

For professional use in gonioscopic examinations.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Fill gonioscopic prism with solution as necessary.

WARNINGS:

WARNINGS SECTION

To avoid contamination do not touch tip of container to any surface. Replace cap after using. Not for use in conjunction with hot laser treatment. If solution changes color or becomes cloudy, do not use.

STORAGE:

STORAGE AND HANDLING SECTION

Store at room temperature 15°- 30°C (59°- 86°F).

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59390-182-13
Goniotaire
Hypromellose 2.5%
Ophthalmic Demulcent
Solution (Sterile)
½ fl oz (15mL)
sterile

PRINCIPAL DISPLAY PANEL NDC 59390-182-13 Goniotaire Hypromellose 2.5% Ophthalmic Demulcent Solution (Sterile) ½ fl oz (15mL) sterilePRINCIPAL DISPLAY PANEL NDC 59390-182-13 Goniotaire Hypromellose 2.5% Ophthalmic Demulcent Solution (Sterile) ½ fl oz (15mL) sterile

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310934hypromellose 2.5 % Ophthalmic SolutionPSN3
310934hypromellose 25 MG/ML Ophthalmic SolutionSCD3
310934hypromellose 2.5 % Ophthalmic SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59390-182-13Goniotaire15 mL in 1 BOTTLESOLUTION153
59390-182-13Goniotaire1 in 1 CARTONSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59390-182GONIOTAIRE (HYPROMELLOSE 2906 (4000 MPA.S)) SOLUTION [ALTAIRE PHARMACEUTICALS INC.]3Legacy NDC, 2 package rows20221101_9ebedd36-523a-4f92-8fe9-33beaf7288f9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59390-182-13ML - Milliliter59390-1828d317a1f-e2f5-4871-bd9b-db280399fff212018-11-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59390-18259390-182-13

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSE 2906 (4000 MPA.S)5EYA69XGATACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM BORATE91MBZ8H3QOIACT
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBCNTM
SODIUM HYDROXIDE55X04QC32ICNTM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3e98cefc-43d0-40bf-80be-651f17a39d4f9ebedd36-523a-4f92-8fe9-33beaf7288f92022-10-28WarningsExact identifier
spl id: 3e98cefc-43d0-40bf-80be-651f17a39d4f
spl set id: 9ebedd36-523a-4f92-8fe9-33beaf7288f9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.