Label: MEIJER ARTIFICIAL TEARS LUBRICANT EYE- polyvinyl alcohol, and 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 29, 2014

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  • ACTIVE INGREDIENT

    Active ingredients                                                               Purpose

    Polyvinyl alcohol 0.5%...................................................... Lubricant

    Povidone 0.6%................................................................. Lubricant

  • PURPOSE

    Uses

    • Relieves dryness of the eye(s)
    • Temporarily relieves burning and irritations due to dryness of the eye
    • Protects against further irritation
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • if solution changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product
  • WHEN USING

    When using this product

    • remove contact lenses before using
    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after each use
  • STOP USE

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse or lasts more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • INDICATIONS & USAGE

    Directions

    • Instill 1 or 2 drops in the affected eye(s) as needed
    • Children under 6 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • some users may experience a brief tingling sensation
    • store at 15° to 25°C (59° to 77°F)

  • INACTIVE INGREDIENT

    benzlkonium chloride, dibasic sodium phosphate hydrate, edetate disodium, glucose, hydrochlorid acid, monobasic sodium phosphate, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate hydrate, sodium hydroxide

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    WWW.MEIJER.COM

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MEIJER ARTIFICIAL TEARS LUBRICANT EYE 
    polyvinyl alcohol, and povidone solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-357
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL5 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-357-151 in 1 CARTON
    115 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/29/2014
    Labeler - Meijer, Inc. (006959555)
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