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

[Akorn Logo]

Mfg. by Akorn, Inc., Lake Forest, IL 60045

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 TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:17478-064
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hypromellose 2906 (4000 MPA.S) (Hypromellose 2906 (4000 MPA.S)) Hypromellose 2906 (4000 MPA.S)25 mg  in 1 mL
Hypromellose 2906 (50 MPA.S) (Hypromellose 2906 (50 MPA.S)) Hypromellose 2906 (50 MPA.S)25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
boric acid 
edetate disodium 
potassium chloride 
sodium borate 
water 
sodium hydroxide 
hydrochloric acid 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-064-121 in 1 CARTON
115 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/1997
Labeler - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc.603980319MANUFACTURE, REPACK, ANALYSIS

Revised: 8/2011
Document Id: 0bf13d29-b5ce-4a34-a6a5-4883a13487b1
Set id: f65ace26-19dc-49ce-832d-96994cfe36e3
Version: 1
Effective Time: 20110805
 
Akorn, Inc.