MURINE TEARS FOR DRY EYES (POLYVINYL ALCOHOL AND POVIDONE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]

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MURINE TEARS FOR DRY EYES (POLYVINYL ALCOHOL AND POVIDONE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]
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NDC 67172-574-01
Set ID e81bb895-0743-460a-88a0-bf57ec729422
Category HUMAN OTC DRUG LABEL
Packager Prestige Brands Holdings, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Polyvinyl alcohol 0.5%

  • Purpose

    Lubricant

  • Active ingredient

    Povidone 0.6%

  • Purpose

    Lubricant

  • Uses

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

    For external use only.

    Do not use

    if solution changes color or becomes cloudy.

    When using this product

    • to avoid contamination, do not touch tip of container to any surface.
    • recap cap after using.

    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 lasts 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 20°- 25°C (68°-77°F)
    • remove contact lenses before using
    • Tamper Evident: Do not use if neckband on bottle is broken or missing.
  • Inactive ingredients

    benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate (mono- and dibasic)

  • Questions?

    1-877-854-0853 www.murine.com


  • PRINCIPAL DISPLAY PANEL

    Murine
    Tears® For DRY EYES
    Lubricant Eye Drops
    Original Natural Tears Formula
    ● Moisture Enriched
    ● Eye Doctor Recommended
    0.5 fl oz. (15 mL)



    PRINCIPAL DISPLAY PANEL Murine Tears® For DRY EYES Lubricant Eye Drops Original Natural Tears Formula ● Moisture Enriched ● Eye Doctor Recommended 0.5 fl oz. (15 mL)

  • INGREDIENTS AND APPEARANCE
    MURINE TEARS FOR DRY EYES 
    polyvinyl alcohol and povidone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-574
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED5 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE6 mg  in 1 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 (UNII: SE337SVY37)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-574-011 in 1 BOX10/01/2012
    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 FINALpart34910/01/2012
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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