Label: OPTASE ALLEGRO- hydroxyethyl cellulose 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 March 23, 2023

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  • ACTIVE INGREDIENT

    0.35% Hydroxyethyl Cellulose

  • 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: Citric Acid,
    Ectoin, Purified Water, Sodium
    Chloride, Trisodium Citrate Dihydrate.

  • 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.

    To avoid contamination, do

    not touch tip to any surface.

    After use, shake the bottle

    downwards in order to remove
    any residual drop that may be left.
    Replace cap after using.
    Stop use and ask doctor if:


    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

    Optase Allegro

  • PRINCIPAL DISPLAY PANEL

    Optase Allegro

  • Immediate Label

    Optase Allegro

  • INGREDIENTS AND APPEARANCE
    OPTASE ALLEGRO 
    hydroxyethyl cellulose solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72972-006
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5) (HYDROXYETHYL CELLULOSE (140 CPS AT 5%) - UNII:8136Y38GY5) HYDROXYETHYL CELLULOSE (140 CPS AT 5%)0.35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ECTOINE (UNII: 7GXZ3858RY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72972-006-011 in 1 BOX03/23/2023
    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 finalM01803/23/2023
    Labeler - Scope Health Inc (116778693)
    Registrant - Regulatory Matters Consulting (080711165)
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