Active:
Hypromellose 25mg (2.5%):
Goniotaire Solution
FDA Label NDC 59390-182
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Altaire Pharmaceuticals Inc. for the product Goniotaire (NDC 59390-182). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active:, inactives:, indications:, directions:, warnings:, storage:, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Indications:
For professional use in gonioscopic examinations.
Directions:
Fill gonioscopic prism with solution as necessary.
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.
Storage:
Store at room temperature 15°- 30°C (59°- 86°F).
Principal Display Panel
NDC 59390-182-13
Goniotaire
Hypromellose 2.5%
Ophthalmic Demulcent
Solution (Sterile)
½ fl oz (15mL)
sterile
Principal Display Panelndc 59390-182-13goniotaire Hypromellose 2.5% Ophthalmic Demulcent Solution (sterile)½ Fl Oz (15ml)sterile (Goniotaire 01)
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