Label: ARTIFICIAL TEARS LUBRICANT EYE- polyvinyl alcohol, povidone 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 December 6, 2019

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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
    ARTIFICIAL TEARS LUBRICANT EYE 
    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 finalpart34901/09/2015
    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)