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GONIOSOFT (hypromellose 2.5%) liquid
[OCuSOFT, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b9885de2-bd4c-c5c8-7ce3-c3f1669e74ea

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		unapproved drug other

NOTE: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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Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
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Medication Guide

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
hypromellose 2.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54799-503
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hypromelloses (Hypromelloses)	Hypromelloses	25 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium Chloride
Boric Acid
Edetate Disodium
Sodium Borate
Water
Hydrochloric Acid
Sodium Hydroxide

Packaging
#	Item Code	Package Description
1	NDC:54799-503-15	15 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/02/1989

Labeler - OCuSOFT, Inc. (174939207)

Establishment
Name	Address	ID/FEI	Business Operations
Altaire Pharmaceuticals, Inc.		786790378	MANUFACTURE(54799-503)

Establishment
Name	Address	ID/FEI	Business Operations
OCuSOFT, Inc.		174939207	MANUFACTURE(54799-503)

Revised: 12/2012

Document Id: 7cbe515b-88df-8f21-88e9-6be068b04565

Set id: b9885de2-bd4c-c5c8-7ce3-c3f1669e74ea

Version: 1

Effective Time: 20121203

OCuSOFT, Inc.

Daily Med

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