Label: ARTIFICIAL 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 November 16, 2011

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  • Active ingredient

    Polyvinyl Alcohol 1.4%

  • Purpose

    Lubricant

  • Uses

    • temporary relieve of burning and irritation due to 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

    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
    • replace cap after use

     

  • Inactive ingredients

    dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,

    purified water, sodium chloride. 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

    DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW IS NOT INTACT.

  • Package/Label Principal Display Panel

    Carton

    NDC 37205-137-05

    LEADER®

    Compare to Liquifilm Tears®* active ingredient*

    Artificial Tears Solution

    Polyvinyl Alcohol 1.4%

    Lubricant Eye Drops

    (Sterile)

    FOR USE IN THE EYES ONLY

    SATISFACTION GUARANTEED 1/2 FL. OZ. (15 mL)

  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS 
    polyvinyl alcohol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-137
    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:37205-137-0515 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/15/2011
    Labeler - Cardinal Health (097537435)
    Registrant - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated807927397MANUFACTURE
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