Label: OPTASE- glycerin 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 February 10, 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 finalM01802/10/2023
    Labeler - Scope Health Inc (116778693)
    Registrant - Regulatory Matters Consulting (080711165)
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