GONIOSOFT- hypromellose 2.5% liquid 
OCuSOFT, 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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Drug Facts

Active ingredient

Hypromellose 2.5%

Purpose

Demulcent

Use

● For professional use in Gonioscopic examinations.

Warnings

● For use in the eyes only. ● 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.

Do not use if solution changes color or becomes cloudy

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poision Control Center right away.

Directions

● Fill Gonioscopic prism with solution as necessary.

Other information

● Store between 15º-30ºC (59º-86ºF). ● Keep tightly closed. ● If this solution dries on optical surfaces, let stand in cool water before cleansing.

DO NOT USE IF IMPRINTED SEAL ON CAP IS TORN, BROKEN OR MISSING.

Inactive ingredients

Benzalkonium Chloride, Boric Acid, Edetate Disodium, Sodium Borate, Water for Injection, Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH.

Questions or Comments?

800-233-5469 or www.ocusoft.com

PRINCIPAL DISPLAY PANEL

GONIOSOFT™ 

NDC 54799-503-15 

Hypromellose 2.5% Ophthalmic Demulcent Solution (Sterile) 

0.5 fl oz (15mL) 

Distributed by OCuSOFT Inc.
Rosenberg, TX 77471 USA
© 2011 OCuSOFT, Inc.
Trademark owned by OCuSOFT, Inc.
Rev. 08/11  

Goniosoft Image
GONIOSOFT 
hypromellose 2.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54799-503
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hypromelloses (UNII: 3NXW29V3WO) (Hypromelloses - UNII:3NXW29V3WO) Hypromelloses25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Boric Acid (UNII: R57ZHV85D4)  
Edetate Disodium (UNII: 7FLD91C86K)  
Sodium Borate (UNII: 91MBZ8H3QO)  
Water (UNII: 059QF0KO0R)  
Hydrochloric Acid (UNII: QTT17582CB)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54799-503-1515 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/02/198901/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/02/198901/31/2022
Labeler - OCuSOFT, Inc. (174939207)
Establishment
NameAddressID/FEIBusiness Operations
Altaire Pharmaceuticals, Inc.786790378MANUFACTURE(54799-503)
Establishment
NameAddressID/FEIBusiness Operations
OCuSOFT, Inc.174939207MANUFACTURE(54799-503)

Revised: 10/2021
Document Id: 773acc2d-60e9-40c5-9d5f-2e4b121e9c80
Set id: b9885de2-bd4c-c5c8-7ce3-c3f1669e74ea
Version: 3
Effective Time: 20211025
 
OCuSOFT, Inc.