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 December 30, 2022

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  • ACTIVE INGREDIENT

    Glycerin 0.9%

  • 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

  • WARNINGS

    Warning
    • For external use only.
    • To avoid contamination, do not touch tip
    of container to any surface. After use, shake the bottle
    downwards in order to remove any residual drop that
    may be left. Replace cap after using.
    • Do not use the solution if it changes color or becomes
    cloudy
    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.

  • DOSAGE & ADMINISTRATION

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

  • INACTIVE INGREDIENT

    Citric Acid Monohydrate, Polyoxyethylenesorbitan Monooleate, Potassium Chloride, Purified Water, Saccha Inchi Seed Oil, Sodium Hyaluronate , Sorbitan Monooleate, Trehalose, Tromethamine

  • OTHER SAFETY INFORMATION

    Patient Information

  • PRINCIPAL DISPLAY PANEL

    Optase

  • INGREDIENTS AND APPEARANCE
    OPTASE 
    glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72972-004
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TREHALOSE (UNII: B8WCK70T7I)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72972-004-011 in 1 BOX02/22/2022
    110 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 finalM01802/22/2022
    Labeler - Scope Health Inc (116778693)
    Registrant - Oy Finnsusp Ab (369374137)
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