Label: FLORIL TEARS- polyvinyl alcohol 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 June 22, 2010

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  • ACTIVE INGREDIENT

    Active ingredients     Purpose


    Polyvinyl Alcohol  1,4%   Lubricant

     

  • When using this product

    • do not touch the tip of the container to any surface to avoid contamination
    • replace cap after each use
    • remove contact lenses before using
  • Stop use and ask a doctor if

    • You feel eye pain
    • changes in vision occur
    • condition worsens or lasts more than 72 hours
  • Keep our of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

  • Inactive ingredients

    Benzalkonium chloride, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, polysorbate 80, sodium chloride, polyethylene glycol 300, purified water.

  • WARNINGS

    For external use only.

    Do not use if the solution changes color or become cloudy.

  • Directions

    • Put 1 to 2 drops in the affected eyes up to times daily.
  • Other information

    Enter section text here

  • Uses

    • temporary relief of eye dryness and redness due to insufficient production of tears.
    • prevents further irritation.
  • PRINCIPAL DISPLAY PANEL

    Floril Tears BoxEnter section text here

  • INGREDIENTS AND APPEARANCE
    FLORIL TEARS 
    polyvinyl alcohol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16995-004
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL14 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) 2 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16995-004-013 mL in 1 BOTTLE, DROPPER
    2NDC:16995-004-0210 mL in 1 BOTTLE, DROPPER
    3NDC:16995-004-0315 mL in 1 BOTTLE, DROPPER
    4NDC:16995-004-0430 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/10/2005
    Labeler - VITALINE S.A.C. (954343687)
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