GONIOVISC OPHTHALMIC LUBRICANT- hypromellose 2910 (4000 mpa.s) solution/ drops 
HUB Pharmaceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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GONIOVISC Eye Lubricant Hypromellose Ophthalmic Solution, USP 2.5%, Drops (Sterile)

ACTIVE INGREDIENTS:

Active Ingredients             Purpose

Hypromellose 25 mg (2.5%)......Lubricant

USES:

Indications & Usage:

For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

WARNINGS:

When using this product

  • To avoid contamination, do not touch tip of container to any surface.

  • Replace cap after using.

Stop use and ask a physician

If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Instill 1 or 2 drops in the affected eye(s) as needed.

OTHER INFORMATION:

INACTIVE INGREDIENTS:

Inactive Ingredients:

Preservative:

Questions?

1-800-Eye-Drop (393-3767)

PACKAGE LABELS:

Goniovisc Bottle Label



Image 1: Label for Bottle

Goniovisc Box Label

Image 2: Label for Box

GONIOVISC  OPHTHALMIC LUBRICANT
hypromellose 2910 (4000 mpa.s) solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17238-610
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 MPA.S) - UNII:RN3152OP35) HYPROMELLOSE 2910 (4000 MPA.S)25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17238-610-151 in 1 BOX11/10/2011
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/10/2011
Labeler - HUB Pharmaceuticals, LLC (611747945)
Establishment
NameAddressID/FEIBusiness Operations
Contacare Ophthalmics & Diagnostics915821765manufacture(17238-610)

Revised: 12/2017
Document Id: 6140e883-8107-44f3-e053-2991aa0a1ba1
Set id: b8b57c41-aae6-4cbd-8fbf-0a1c6fa196d9
Version: 5
Effective Time: 20171226
 
HUB Pharmaceuticals, LLC