Label: LIQUITEARS- 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 March 9, 2012

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  • Active ingredient

    Polyvinyl Alcohol 1.4%

  • Purpose

    Lubricant

  • Uses

    • to prevent further irritation
    • to relieve dryness of the eye
  • Warnings

    • Do not use if solution changes color or becomes cloudy

    When using this product  

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after use

    Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye
    • condition worsens or persists for more than 72 hours
  • Keep out of reach of children.

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

  • Directions

    • instill 1 to 2 drops in the affected eye(s) as needed
  • Other information

    • store at 15° - 30°C (59° - 86°F)
    • keep tightly closed

     

  • Inactive ingredients

    dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, sodium chloride,

    purified water. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%

  • Questions ?

    Serious side effects associated with use of this product may be reported to 1800-323-0000

    *MAJOR LIQUITEARS IS NOT MANUFACTURED OR DISTRIBUTED BY ALLERGAN, INC. OWNER OF THE REGISTERED TRADEMARK, LIQUIFILM TEARS®.

  • Package/Label Principal Display Panel

    Carton

    MAJOR®

    NDC 0904-5017-35

    LiquiTears

    Polyvinyl Alcohol 1.4%

    Lubricant Eye Drops (Sterile)

    Relieves Burning due to Dryness of the Eye

    Compare to Active Ingredient of Liquifilm Tears®*

    1/2 FL. OZ. (15 mL)

    Repacked by:
    H.J. Harkins Company, Inc.
    Grover Beach, CA 93433

  • INGREDIENTS AND APPEARANCE
    LIQUITEARS 
    polyvinyl alcohol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-041(NDC:0904-5017)
    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
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52959-041-0015 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/09/2011
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Registrant - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated807927397MANUFACTURE
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