Label: SPLASH TEARS- hypromellose solution/ drops

  • NDC Code(s): 57619-303-01, 57619-303-03
  • Packager: LABORATORIOS SOPHIA, S.A. DE C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Hypromellose 0.2%

  • PURPOSE

    Purpose

    Lubricant eye drops

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves

    • burning and irritation due to dryness of the eye.
    • discomfort due to minor irritations of the eye or to exposure to wind or sun.
  • WARNINGS

    Warnings

    For external use only.

    Do not use if solution changes color or becomes cloudy.

    When using this product

    • do not touch tip of container to any surface to avoid contamination.
    • replace cap after using.

    Stop use and ask a doctor if

    • you experience 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

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

  • STORAGE AND HANDLING

    Other information

    • store at room temperature
    • do not use if imprinted seal around cap is broken.
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, boric acid, chondroitin sulfate, decahydrate edetate disodium, magnesium chloride hexahydrate, polysorbate 80, potassium chloride, sodium borate, sodium chloride, water for injection

  • QUESTIONS

    Questions?

    Call 1-866-282-8871

    www.splashtears.com

  • SPL UNCLASSIFIED SECTION

    NDC 57619-303-01

    Distributed by:

    LABS SOPHIA USA, INC.

    1790 Hughes Landing Blvd Suite 400

    The Woodlands, TX 77380

    MADE IN MEXICO

    www.splashtears.com

  • PRINCIPAL DISPLAY PANEL

    LONG LASTING

    Splash TEARS®

    Lubricant Eye Drops

    Dry Eye Relief

    Fast-Acting Hydration

    1/2 FL OZ (15 mL)

    STERILE

    SPLASH TEARS - Dec 2021

  • INGREDIENTS AND APPEARANCE
    SPLASH TEARS 
    hypromellose solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57619-303
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 MPA.S) - UNII:RN3152OP35) HYPROMELLOSE 2910 (4000 MPA.S)0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    BORIC ACID (UNII: R57ZHV85D4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57619-303-011 in 1 CARTON05/13/2020
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:57619-303-031 in 1 CARTON07/24/2020
    22 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 DrugM01805/13/2020
    Labeler - LABORATORIOS SOPHIA, S.A. DE C.V. (810143636)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS SOPHIA, S.A. DE C.V.810143636manufacture(57619-303)
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