Label: ONEDROP- propylene glycol liquid

  • NDC Code(s): 57619-306-01, 57619-306-02
  • Packager: LABORATORIOS SOPHIA, S.A. DE C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 18, 2025

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Propylene Glycol 0.6%

  • PURPOSE

    Purpose

    Lubricant eye drops

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of burning and irritation due
    to dryness of the eye.

  • WARNINGS

    Warnings

    For external use only

    Do not use

    • If this product changes color or becomes cloudy
    • If you are sensitive to any ingredient in this product.
    • Do not use if imprinted seal around cap is broken or bottle is damaged

    When using this product

    • Make sure the tip of container does not touch any surface to avoid contamination.
    • Replace cap after each use

    Stop use and ask a doctor if you experience any of the following:

    • Eye pain, changes in vision, continued redness or irritation of the eye
    • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Shaking is not required
    • Instill 1 or 2 drops in the affected eye(s) as needed.

  • Other information

    Store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients

    Boric acid, castor oil, dimyristoyl phosphatidylcholine (DMPC), disodium edetate dihydrate, glycerin,hyaluronate sodium, polysorbate 80, sodium borate decahydrate, water for injection.

  • QUESTIONS

    Questions?

    Call +1 (612) 584-9232
    www.TearRestore.com
    Contact@TearRestore.com

  • SPL UNCLASSIFIED SECTION

    For external use only. See Drug Facs for complete directions and safety information.

    NDC: 57619-306-01

    Distributed By

    TearRestore Inc.

    Arden Hills, MN 55112 USA

    Country of Origin Mexico

    www.TearRestore.com

  • PRINCIPAL DISPLAY PANEL

    TearRestore

    OneDrop

    PRESERVATIVE FREE

    Lubricant Eye Drops

    Hyaluronic Acid

    Safe with Contacts
    Blur-Free Formulation

    Propylene Glycol 0.6%

    10mL / 0.34 Fl. Oz. Bottle

    box label

    bottle label

  • Sample box label

    sample box label

  • INGREDIENTS AND APPEARANCE
    ONEDROP 
    propylene glycol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57619-306
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- (UNII: U86ZGC74V5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57619-306-011 in 1 BOX08/18/2025
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:57619-306-021 in 1 BOX08/18/2025
    210 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 DrugM01808/18/2025
    Labeler - LABORATORIOS SOPHIA, S.A. DE C.V. (810143636)
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