Label: WINCO ARTIFICIAL TEARS LUBRICANT EYE DROPS- polyvinyl alcohol, povidone solution/ drops

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 23, 2023

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  • ACTIVE INGREDIENT

    ​Active ingredients

    Polyvinyl alcohol 0.5%

    Povidone 0.6%

  • PURPOSE

    ​Purpose

    Polyvinyl alcohol: Eye Lubricant

    Povidone: Eye Lubricant

  • INDICATIONS & USAGE

    Uses:

    • for use as a protectant against further irritation or to relieve dryness of the eye
    • for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
  • WARNINGS

    Warnings

    For external use only

    • Do not use this product if solution changes color or becomes cloudy

    Stop use and ask a doctor if you experience

    • eye pain
    • changes in vision
    • continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours

    When using this product

    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after using. Keep container tightly closed
    • remove contact lens before using

    Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    Instill 1 or 2 drops in the affected eye(s) as needed.

  • OTHER SAFETY INFORMATION

    Other information

    • Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
    • RETAIN THIS CARTON FOR FUTURE REFERENCE
    • Store at 15°-30°C (59°-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, and sodium phosphate monobasic

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    WINCO ARTIFICIAL TEARS LUBRICANT EYE DROPS 
    polyvinyl alcohol, povidone solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-284
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL500 mg  in 100 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE600 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-284-151 in 1 BOX01/09/2015
    115 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 DrugM01801/09/2015
    Labeler - WinCo Foods, LLC (056098817)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(67091-284) , label(67091-284) , pack(67091-284)
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