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
  • Marketing Status: OTC monograph final

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 May 8, 2023

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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, decahydrate edetate disodium, magnesium chloride hexahydrate, 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 finalpart34904/25/2023
    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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