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OASIS Tears (OASIS Medical, Inc.)

Available Formats

Dosage Form Package Information Links
SOLUTION/ DROPS 5 VIAL, SINGLE-USE in 1 POUCH (42126-6100-2) > .3 mL in 1 VIAL, SINGLE-USE Label Information
SOLUTION/ DROPS 3 POUCH in 1 CARTON (42126-6100-1) > 10 VIAL, SINGLE-USE in 1 POUCH > .3 mL in 1 VIAL, SINGLE-USE Label Information

Complete OASIS Tears Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredients

    Glycerin (0.22%)


  • Purpose

    lubricant Eye Drops


  • Uses

    • For the temporary relief of burning and irritation due to dryness of the eye
    • For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
    • For use as a protectant against further irritation or to relieve dryness of the eye
    • For use as a lubricant to prevent further irritation or to relieve dryness of the eye

  • Warnings

    For external use only

    Do not use
    • If solution changes color or becomes cloudy
    • If you are sensitive to any ingredient in this product

    When using this product
    • To avoid contamination do not touch tip of container to any surface
    • Once opened, discard
    • Do not reuse

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


  • Directions

    Instill 1 or 2 drops in the affected eye(s) as needed.


  • Questions, or to report an adverse event call

    (800) 631-7180 or (909) 305-5400 or log onto www.oasistears.com


  • Other information

    • Protect from light and freezing
    • Store at or below 77°F/25°C

  • Inactive Ingredients

    Sodium Hyaluronate, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, water


  • PRINCIPAL DISPLAY PANEL - 0.3 ML Container Carton

    N 42126-6100-1

    Oasis
    TEARS®

    PRESERVATIVE-FREE
    LUBRICANT EYE DROPS

    VISCOADAPTIVE RELIEF
    FOR DRY EYES

    30
    STERILE (0.3 ML/0.01 FL. OZ.)
    SINGLE USE CONTAINERS

    PRINCIPAL DISPLAY PANEL - 0.3 ML Container Carton

  • INGREDIENTS AND APPEARANCE
    OASIS TEARS  PRESERVATIVE-FREE LUBRICANT EYE
    glycerin solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42126-6100
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin .22 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Hyaluronate Sodium (UNII: YSE9PPT4TH) 0.15 g  in 100 mL
    Sodium chloride (UNII: 451W47IQ8X)  
    Sodium phosphate, monobasic, unspecified form (UNII: 3980JIH2SW)  
    Sodium phosphate, dibasic, unspecified form (UNII: GR686LBA74)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42126-6100-1 3 in 1 CARTON 11/01/2017
    1 10 in 1 POUCH
    1 0.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2 NDC:42126-6100-2 5 in 1 POUCH 11/01/2017
    2 0.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 11/01/2007
    Labeler - OASIS Medical, Inc. (194121018)
    Establishment
    Name Address ID/FEI Business Operations
    OASIS Medical, Inc. 194121018 MANUFACTURE(42126-6100)
    Establishment
    Name Address ID/FEI Business Operations
    Laboratoire Unither 574139809 MANUFACTURE(42126-6100)