AVITEARS (POLYSORBATE 80) SOLUTION/ DROPS [PINNACLE SCIENCE, LLC]

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AVITEARS (POLYSORBATE 80) SOLUTION/ DROPS [PINNACLE SCIENCE, LLC]
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NDC 49869-002-01, 49869-002-02
Set ID dbb0d312-c79a-4c89-acb1-b895b52c05d5
Category HUMAN OTC DRUG LABEL
Packager Pinnacle Science, LLc
Generic Name
Product Class
Product Number
Application Number PART349
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  • Drug Facts

  • Active Ingredient

    Polysorbate 80, 1%

  • Purpose

    Lubricant

  • Uses

    • Temporary relief of discomfort, burning and irritation due to dryness of the eye or from exposure to wind, sun, computer use, environmental conditions, prescription medication, post-surgical dry eye or systemically induced dry eye.
    • Lubricant and protectant from further irritation
  • Warnings

    • For external use only
    • To avoid contamination replace cap after use
    • Do not touch the tip of the container to any surface to avoid contamination
    • Do not use 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, or if condition persists for more than 72 hours or worsens
    • Keep this and all other drugs out of the reach of children
  • Directions

    • Instill one or two drops in the affected eye(s) as needed
  • Other Information

    Store at 20 to 25° C (68 to 77° F)

    Controlled USP Room Temperature

  • Inactive Ingredients

    Citric acid, edetate disodium, WFI water, sodium chloride and the antioxidants: mannitol, pyruvate, retinyl palmitate and sodium citrate.

  • Principal Display Panel 10mL Bottle Label

    AvitearsTM

    Lubrication Eye Drops

    0.33 FL.OZ

    (10mL)

    Maximum Strength for Dry Eyes

    Principal Display Panel 10mL Bottle Label
  • Principal Display Panel 10mL Carton Label

    Sterile

    AvitearsTM

    Lubrication Eye Drops

    .33 FL.OZ

    (10mL)

    No Preservatives

    Antioxidant Based

    Maximum Strength for Dry Eyes

    Principal Display Panel 10mL Carton Label
  • Principal Display Panel 15mL Bottle Label

    AvitearsTM

    Lubrication Eye Drops

    0.5 FL.OZ

    (15mL)

    Maximum Strength for Dry Eyes

    Principal Display Panel 15mL Bottle Label
  • Principal Display Panel 15mL Carton Label

    Sterile

    AvitearsTM

    Lubrication Eye Drops

    .5 FL.OZ

    (15mL)

    No Preservatives

    Antioxidant Based

    Maximum Strength for Dry Eyes

    Principal Display Panel 15mL Carton Label
  • INGREDIENTS AND APPEARANCE
    AVITEARS 
    polysorbate 80 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49869-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    polysorbate 80 (UNII: 6OZP39ZG8H) (polysorbate 80 - UNII:6OZP39ZG8H) polysorbate 8010 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    sodium citrate (UNII: 1Q73Q2JULR)  
    sodium chloride (UNII: 451W47IQ8X)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    mannitol (UNII: 3OWL53L36A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49869-002-0210 mL in 1 BOTTLE, PLASTIC
    2NDC:49869-002-0115 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/17/2009
    Labeler - Pinnacle Science, LLc (828202494)
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