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

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 February 2, 2018

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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 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 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) Glycerin.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 finalpart34911/01/2007
    Labeler - OASIS Medical, Inc. (194121018)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS Medical, Inc.194121018MANUFACTURE(42126-6100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoire Unither574139809MANUFACTURE(42126-6100)