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

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.

----------

GONAK™
Hypromellose Ophthalmic Demulcent Solution
2.5%

FOR OPHTHALMIC USE ONLY

Indications: For Professional use in gonioscopic examinations.

Directions: Fill gonioscopic prism with solution as necessary.

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 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 Text for Container Label:

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]

Principal Display Panel Text for Carton Label:

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:17478-064-12	1 in 1 CARTON	01/01/1997	12/01/2021
1		15 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		01/01/1997	12/01/2021

Labeler - Akorn (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696840	MANUFACTURE(17478-064) , ANALYSIS(17478-064) , PACK(17478-064) , LABEL(17478-064) , STERILIZE(17478-064)

Revised: 1/2022

Document Id: 389198d3-d7d9-4bd2-8846-ce183a66f1f7

Set id: f65ace26-19dc-49ce-832d-96994cfe36e3

Version: 5

Effective Time: 20220127

Akorn

GONAK™Hypromellose Ophthalmic Demulcent Solution2.5%

WARNINGS:

GONAK™
Hypromellose Ophthalmic Demulcent Solution
2.5%