Label: GONIOSOFT - hypromelloses liquid 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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  • Active ingredient

    Hypromellose 2.5%

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  • Purpose

    Demulcent

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  • Use

    For professional use in Gonioscopic examinations.

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  • Warnings

    For use in the eyes only. 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.

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  • Do not use if solution changes color or becomes cloudy
  • KEEP OUT OF REACH OF CHILDREN.

    If swallowed, get medical help or contact a Poision Control Center right away.

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  • Directions

    Fill Gonioscopic prism with solution as necessary.

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  • Other information

    Store between 15º-30ºC (59º-86ºF). Keep tightly closed. If this solution dries on optical surfaces, let stand in cool water before cleansing.

    DO NOT USE IF IMPRINTED SEAL ON CAP IS TORN, BROKEN OR MISSING.

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  • Inactive ingredients

    Benzalkonium Chloride, Boric Acid, Edetate Disodium, Sodium Borate, Water for Injection, Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH.

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  • Questions or Comments?

    800-233-5469 or www.ocusoft.com

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  • PRINCIPAL DISPLAY PANEL

    GONIOSOFT™ 

    NDC 54799-503-15 

    Hypromellose 2.5% Ophthalmic Demulcent Solution (Sterile)
     

    0.5 fl oz (15mL) 

    Distributed by OCuSOFT Inc.
    Rosenberg, TX 77471 USA
    © 2011 OCuSOFT, Inc.
    Trademark owned by OCuSOFT, Inc.
    Rev. 08/11  

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  • INGREDIENTS AND APPEARANCE
    GONIOSOFT  
    hypromellose 2.5% liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54799-503
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hypromelloses (Hypromelloses) Hypromelloses 25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Benzalkonium Chloride  
    Boric Acid  
    Edetate Disodium  
    Sodium Borate  
    Water  
    Hydrochloric Acid  
    Sodium Hydroxide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54799-503-15 15 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/02/1989
    Labeler - OCuSOFT, Inc. (174939207)
    Establishment
    Name Address ID/FEI Business Operations
    Altaire Pharmaceuticals, Inc. 786790378 MANUFACTURE(54799-503)
    Establishment
    Name Address ID/FEI Business Operations
    OCuSOFT, Inc. 174939207 MANUFACTURE(54799-503)
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