Label: GONIOTAIRE (hypromellose 2906- 4000 mpa.s solution

  • NDC Code(s): 59390-182-13
  • Packager: Altaire Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated January 20, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Altaire

    Goniotaire

    Hypromellose 2.5% Ophthalmic

    Demulcent Solution

     15mL

    NDC 59390-182-13

    Drug Facts

    Each mL Contains:

  • Active:

    Hypromellose 25mg (2.5%):

  • Inactives:

    Benzalkonium Chloride, Boric Acid, Edetate Disodium, Sodium Borate, Water for injection. Hydrochloric Acid and/or sodium hydroxide may be added to adjust pH (6.0 to 7.8).

    NOTE: If this solution dries on optical surfaces, let them stand in cool water before cleansing.

  • INDICATIONS:

    For professional use in gonioscopic examinations.

  • DIRECTIONS:

    Fill gonioscopic prism with solution as necessary.

  • 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.

  • KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

  • STORAGE:

    Store at room temperature 15°- 30°C (59°- 86°F).

  • PRINCIPAL DISPLAY PANEL

    NDC 59390-182-13
    Goniotaire
    Hypromellose 2.5%
    Ophthalmic Demulcent
    Solution (Sterile)
    ½ fl oz (15mL)
    sterile

    PRINCIPAL DISPLAY PANEL
NDC 59390-182-13
Goniotaire 
Hypromellose 2.5% 
Ophthalmic Demulcent 
Solution (Sterile)
½ fl oz (15mL)
sterile

  • INGREDIENTS AND APPEARANCE
    GONIOTAIRE 
    hypromellose 2906 (4000 mpa.s) solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59390-182
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPROMELLOSE 2906 (4000 MPA.S) (UNII: 5EYA69XGAT) (HYPROMELLOSE 2906 (4000 MPA.S) - UNII:5EYA69XGAT) HYPROMELLOSE 2906 (4000 MPA.S)25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59390-182-131 in 1 CARTON01/18/2002
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/18/2002
    Labeler - Altaire Pharmaceuticals Inc. (786790378)