GONAK™ Hypromellose Ophthalmic Demulcent Solution 2.5%

Manufacturer: Akorn | Akorn Operating Company LLC
Effective date: 2022-01-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 22:11:19

Label at a glance#

ProductGonak Hypromellose

Active ingredientHypromellose 2906 (4000 MPA.S), Hypromellose 2906 (50 MPA.S)

Label structure10 sections

Storage and handling

Storage: Store at 15° to 30°C (59° to 86°F).

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

FOR OPHTHALMIC USE ONLY

INDICATIONS & USAGE SECTION

Indications: For Professional use in gonioscopic examinations.

DOSAGE & ADMINISTRATION SECTION

Directions: Fill gonioscopic prism with solution as necessary.

STORAGE AND HANDLING SECTION

Storage: Store at 15° to 30°C (59° to 86°F).

WARNINGS:

WARNINGS SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

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%.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL.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 Text for Container Label:

PACKAGE LABEL.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]

Principal Display Panel Text for Carton Label:

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-064-12	ML - Milliliter	17478-064	1b221145-bb1e-440f-b5f9-33b62ae4ef7a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Hypromellose 2906 (4000 MPA.S)	ACTIVE INGREDIENT	5EYA69XGAT	1
Hypromellose 2906 (50 MPA.S)	ACTIVE INGREDIENT	612E703ZUQ	1
Hypromellose 2906 (4000 MPA.S)	ACTIVE MOIETY	5EYA69XGAT	1
Hypromellose 2906 (50 MPA.S)	ACTIVE MOIETY	612E703ZUQ	1
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	1
potassium chloride	INACTIVE INGREDIENT	660YQ98I10	1
sodium borate	INACTIVE INGREDIENT	91MBZ8H3QO	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Gonak Hypromellose
Hypromellose 2906 (4000 MPA.S) and Hypromellose 2906 (50 MPA.S)
Hypromellose 2906 (4000 MPA.S)
Hypromellose 2906 (50 MPA.S)
boric acid
edetate disodium
potassium chloride
sodium borate
water
sodium hydroxide
hydrochloric acid

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17478-064	17478-064-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Hypromellose 2906 (4000 MPA.S)	5EYA69XGAT	ACTIB
Hypromellose 2906 (50 MPA.S)	612E703ZUQ	ACTIB
boric acid	R57ZHV85D4	IACT
edetate disodium	7FLD91C86K	IACT
potassium chloride	660YQ98I10	IACT
sodium borate	91MBZ8H3QO	IACT
water	059QF0KO0R	IACT
sodium hydroxide	55X04QC32I	IACT
hydrochloric acid	QTT17582CB	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 440 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION, CONCENTRATE / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	JELLY / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / TOPICAL		70 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL, METERED / TRANSDERMAL		350 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	LIQUID / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
potassium chloride	POTASSIUM CHLORIDE	660YQ98I10	INJECTION, SOLUTION / INTRAVENOUS		330 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTABLE, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION/ DROPS / TOPICAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / SUBCONJUNCTIVAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / SUBARACHNOID	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	160 mg		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SPRAY, METERED / NASAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRATUMOR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBCUTANEOUS	31.45 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
potassium chloride	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION / OPHTHALMIC	0.22 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium borate	SODIUM BORATE	91MBZ8H3QO	SUSPENSION/ DROPS / OPHTHALMIC	0.03 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRA-ARTERIAL		840 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, EMULSION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
potassium chloride	POTASSIUM CHLORIDE	660YQ98I10	INJECTION / INTRAVENOUS		1 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAPERITONEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	CAPSULE / ORAL	60 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	MOUTHWASH / BUCCAL	2 mg/1ml		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	POWDER, FOR SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / ORAL		223 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-ARTERIAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED / ORAL	0.08 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	EMULSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / URETHRAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / INTRAOCULAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVENOUS		456 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / RECTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
389198d3-d7d9-4bd2-8846-ce183a66f1f7			f65ace26-19dc-49ce-832d-96994cfe36e3	2022-01-27	Warnings	Exact identifier spl set id: f65ace26-19dc-49ce-832d-96994cfe36e3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.