Label: OASIS TEARS PRESERVATIVE-FREE LUBRICANT EYE- glycerin solution/ drops

  • NDC Code(s): 42126-6100-1, 42126-6100-2
  • Packager: OASIS Medical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2024

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  • 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 conditions 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) and above 32°F (0°C).
  • Inactive Ingredients

    Sodium chloride, sodium hyaluronate, sodium phosphate dibasic, sodium phosphate monobasic, water.

  • PRINCIPAL DISPLAY PANEL - 0.3 mL Pouch 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 Pouch Carton
  • INGREDIENTS AND APPEARANCE
    OASIS TEARS  PRESERVATIVE-FREE LUBRICANT EYE
    glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42126-6100
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.22 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42126-6100-13 in 1 CARTON11/01/2017
    110 in 1 POUCH
    10.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:42126-6100-25 in 1 POUCH11/01/2017
    20.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM01811/01/2007
    Labeler - OASIS Medical, Inc. (194121018)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATOIRE UNITHER COUTANCES574139809MANUFACTURE(42126-6100)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNITHER MANUFACTURING LLC079176615MANUFACTURE(42126-6100)
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