GONAK HYPROMELLOSE (hypromellose 2906 (4000 mpa.s) and hypromellose 2906- 50 mpa.s solution

Gonak Hypromellose by

Drug Labeling and Warnings

Gonak Hypromellose by is a Prescription medication manufactured, distributed, or labeled by Akorn, Akorn Operating Company LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

FOR OPHTHALMIC USE ONLY

INDICATIONS & USAGE

Indications: For Professional use in gonioscopic examinations.

DOSAGE & ADMINISTRATION

Directions: Fill gonioscopic prism with solution as necessary.

STORAGE AND HANDLING

Storage: Store at 15° to 30°C (59° to 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.

DO NOT USE IF IMPRINTED SEAL ON BOTTLE NECK IS BROKEN OR MISSING

Each mL contains:
Active: Hypromellose 52906, 25mg (2.5%).

Inactives: Boric Acid, Edetate Disodium, Potassium Chloride, Sodium Borate, Purified Water, Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.0 to 7.8).

Preservative: Benzalkonium Chloride 0.01%.

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 17478-064-12

Gonak™

Hypromellose

Ophthalmic

Demulcent

Solution

2.5%

For Professional Use In

Gonioscopic Examinations

FOR OPTHALMIC USE ONLY

15 mL Sterile

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC: 17478-064-12

Gonak™

Hypromellose

Ophthalmic

Demulcent

Solution

2.5%

For Professional Use In

Gonioscopic Examinations

15 mL

Sterile

[Akorn Logo]

INGREDIENTS AND APPEARANCE

GONAK HYPROMELLOSE 
hypromellose 2906 (4000 mpa.s) and hypromellose 2906 (50 mpa.s) solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 17478-064
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hypromellose 2906 (4000 MPA.S) (UNII: 5EYA69XGAT) (Hypromellose 2906 (4000 MPA.S) - UNII:5EYA69XGAT)	Hypromellose 2906 (4000 MPA.S)	25 mg  in 1 mL
Hypromellose 2906 (50 MPA.S) (UNII: 612E703ZUQ) (Hypromellose 2906 (50 MPA.S) - UNII:612E703ZUQ)	Hypromellose 2906 (50 MPA.S)	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
boric acid (UNII: R57ZHV85D4)
edetate disodium (UNII: 7FLD91C86K)
potassium chloride (UNII: 660YQ98I10)
sodium borate (UNII: 91MBZ8H3QO)
water (UNII: 059QF0KO0R)
sodium hydroxide (UNII: 55X04QC32I)
hydrochloric acid (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17478-064-12	1 in 1 CARTON	01/01/1997
1		15 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/01/1997

Labeler - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		603980319	MANUFACTURE(17478-064) , REPACK(17478-064) , ANALYSIS(17478-064)