GONIOVISC OPHTHALMIC LUBRICANT (hypromellose 2910- 4000 mpa.s solution/ drops

Goniovisc by

Drug Labeling and Warnings

Goniovisc by is a Otc medication manufactured, distributed, or labeled by HUB Pharmaceuticals, LLC, Contacare Ophthalmics & Diagnostics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Active Ingredients             Purpose

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

USES:

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

Indications & Usage:

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

WARNINGS:

• For external use only.
• Do not use if sealed bottle tip is broken or punctured.
• If solution changes color or becomes cloudy, do not use.

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:

• Store at room temperature 15°-30°C (59°-86°F).
• Do not freeze.
• Keep box for complete information.

INACTIVE INGREDIENTS:

Inactive Ingredients:

• Boric Acid
• Edetate Disodium
• Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.0-7.8)

• Sodium Borate

• Water for Injection

Preservative:

• Benzalkonium Chloride Solution NF 0.02% v/v

Questions?

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

PACKAGE LABELS:

Image 1: Label for Bottle

Image 2: Label for Box

INGREDIENTS AND APPEARANCE

GONIOVISC  OPHTHALMIC LUBRICANT
hypromellose 2910 (4000 mpa.s) solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17238-610
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17238-610-15	1 in 1 BOX	11/10/2011
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	11/10/2011

Labeler - HUB Pharmaceuticals, LLC (611747945)

Establishment
Name	Address	ID/FEI	Business Operations
Contacare Ophthalmics & Diagnostics		915821765	manufacture(17238-610)