Label: SPLASH REDNESS RELIEVER- hypromellose, naphazoline hydrochloride solution/ drops

  • NDC Code(s): 57619-304-01
  • Packager: LABORATORIOS SOPHIA, S.A. DE C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 28, 2024

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient . . . . . . . . . . . . . . . . Purpose
    Hypromellose 0.2%............................Lubricant
    Naphazoline hydrochloride 0.02%.....Redness reliever

  • PURPOSE

    Purpose

  • Uses

    Temporarily relieves

    • redness due to minor eye irritation
    • protection against further irritation
    • burning and irritation due to dryness of the eye
  • 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.

    ask a doctor before use if you have narrow angle glaucoma.

    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.
    • overuse may cause more redness of the eye
    • pupil may become enlarged temporarily

    Keep out of reach of children.

    If swallowed, get medical help or contat a Poison Control Center right away

  • Directions

    Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.

  • Other information

    • store at room temperature
    • do not use if imprinted seal around cap is broken
    • remove contact lenses before using
  • Inactive ingredients

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

  • Questions?

    Call 1-866-282-8871

    splashtears.com

  • PRINCIPAL DISPLAY PANEL

    Splash ®
    Redness Reliever
    Lubricant redness reliever Eye drops

    Fast-Acting Reliever
    0.5 FL OZ (15 mL)


    Relieves REDNESS BURNING IRRITATION
    Sophia ®


    Distributed by:
    LABS SOPHIA USA, INC
    1790 Hughes Landing Blvd, Suite 400
    The Woodlands, TX 77380
    MADE IN MEXICO

    label

  • INGREDIENTS AND APPEARANCE
    SPLASH REDNESS RELIEVER 
    hypromellose, naphazoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57619-304
    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
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57619-304-011 in 1 CARTON04/25/2023
    115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01804/25/2023
    Labeler - LABORATORIOS SOPHIA, S.A. DE C.V. (810143636)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS SOPHIA, S.A. DE C.V.810143636manufacture(57619-304)
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