Label: ARTIFICAL TEARS- 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 20, 2018

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  • ACTIVE INGREDIENT

    Active ingredients                                  Purpose

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

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

  • PURPOSE

    Uses

    • For the temporary relief of burning & irritation due to dryness of the eye
    • For use as a protectant against further irritation or to relieve dryness of the eye
  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    • if solution changes color or becomes cloudy.
  • WHEN USING

    When using this product

    • to avoid contamination, do not touch tip to any surface
    • replace cap after using

  • STOP USE

    Stop use and ask a doctor if

    • you experience eye pain
    • you experience changes in vision
    • you experience continued redness or irritation of the eye
    • the condition worsens
    • symptoms last for 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.
    • store at room temperature
    • remove contact lenses before using
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Geiss, Destin & Dunn, Inc.

    Peachtree, City, GA 30269

    www.valuelabels.com

    1-866-696-0957

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    pdp

  • INGREDIENTS AND APPEARANCE
    ARTIFICAL TEARS 
    polyvinyl alcohol, and povidone solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45865-744(NDC:50804-017)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL0.05 g  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE0.06 g  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, DIHYDRATE (UNII: 5QWK665956)  
    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:45865-744-011 in 1 PACKAGE06/01/2018
    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 finalpart34904/04/2016
    Labeler - medsource pharmaceuticals (833685915)
    Establishment
    NameAddressID/FEIBusiness Operations
    medsource pharmaceuticals833685915repack(45865-744)
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