Goniotaire

Goniotaire
SPL v3
SPL
SPL Set ID 9ebedd36-523a-4f92-8fe9-33beaf7288f9
Route
OPHTHALMIC
Published
Effective Date 2022-10-28
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hypromellose 2906 (4000 Mpa.s) (25 mg)
Inactive Ingredients
Benzalkonium Chloride Boric Acid Edetate Disodium Sodium Borate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2002-01-18

Description

Altaire Goniotaire Hypromellose 2.5% Ophthalmic Demulcent Solution   15mL NDC 59390- 182-13 Drug Facts Each m L Contains:


Medication Information

Description

Altaire Goniotaire Hypromellose 2.5% Ophthalmic Demulcent Solution   15mL NDC 59390- 182-13 Drug Facts Each m L Contains:

Active

Hypromellose 25mg (2.5%):

Section 42229-5

Altaire

Goniotaire

Hypromellose 2.5% Ophthalmic

Demulcent Solution

 15mL

NDC 59390- 182-13

Drug Facts

Each m L Contains:

Storage:

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

Warnings:

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.

Inactives:

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.

Directions:

Fill gonioscopic prism with solution as necessary.

Indications:

For professional use in gonioscopic examinations.

Principal Display Panel

NDC 59390-182-13

Goniotaire

Hypromellose 2.5%

Ophthalmic Demulcent

Solution (Sterile)

½ fl oz (15mL)

sterile


Structured Label Content

Active

Hypromellose 25mg (2.5%):

Section 42229-5 (42229-5)

Altaire

Goniotaire

Hypromellose 2.5% Ophthalmic

Demulcent Solution

 15mL

NDC 59390- 182-13

Drug Facts

Each m L Contains:

Storage: (STORAGE:)

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

Warnings: (WARNINGS:)

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.

Inactives:

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.

Directions: (DIRECTIONS:)

Fill gonioscopic prism with solution as necessary.

Indications: (INDICATIONS:)

For professional use in gonioscopic examinations.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 59390-182-13

Goniotaire

Hypromellose 2.5%

Ophthalmic Demulcent

Solution (Sterile)

½ fl oz (15mL)

sterile


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)