Label: OPTASE- glycerin solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 19, 2023

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  • ACTIVE INGREDIENT

    0.25 % glycerin

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If swallowed get medical
    help or contact a poison
    control center right away.

  • PURPOSE

    Eye Lubricant

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Borax, Boric Acid, Citric Acid
    anhydrous, Sodium Chloride,
    Sodium Citrate Dihydrate,
    Sodium Hyaluronate, water.

  • DOSAGE & ADMINISTRATION

    Directions:
    Put one or two drops in the
    affected eyes as needed.

  • WARNINGS

    Warning
    • For external use only.
    • If solution changes color or
    becomes cloudy, do not use.


    Stop use and ask doctor if
    • You feel eye pain.
    • Changes in vision occur.
    • Redness or irritation of the eye lasts.
    • Condition worsens or lasts
    more than 72 hours

  • INDICATIONS & USAGE

    Uses
    • For use as a lubricant to prevent
    further irritation.
    • May be used as a protectant against
    further irritation.
    • To relieve dryness of the eye.

  • Patient Information Leaflet- Page 1

    Instructions for use

  • Patient Information Leaflet- Page 2

    Instructions for use

  • PRINCIPAL DISPLAY PANEL

    Optase Hylo Relief

  • Immediate label

    Optase Hylo Relief

  • INGREDIENTS AND APPEARANCE
    OPTASE 
    glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72972-005
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BORIC ACID (UNII: R57ZHV85D4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72972-005-011 in 1 BOX02/10/2023
    110 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01802/10/2023
    Labeler - Scope Health Inc (116778693)
    Registrant - Regulatory Matters Consulting (080711165)
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