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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 26, 2017

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  • 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:

    Goniovisc Bottle Label



    Image 1: Label for Bottle

    Goniovisc Box Label

    Image 2: Label for Box

  • INGREDIENTS AND APPEARANCE
    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)
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