Label: SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT- dextran, polyethylene glycol 400, povidone, tetrahydrozoline solution/ drops

  • NDC Code(s): 49348-697-29
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

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Updated December 23, 2023

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  • Active Ingredients

    Dextran 70 0.1%
    povidone 1%
    Polyethylene glycol 400 1%
    Tetrahydrozoline HCL 0.05%

  • Purpose

    Eye Lubricant

    Redness reliever

  • Uses

    • relieves redness of the eye due to minor eye irritations
    • as a lubricant to prevent further irritation or to relieve dryness of the eye

  • Warnings

    For external use only

    Ask a doctor before use if you have

    narrow angle glucoma

    When using this product

    • pupils may become enlarged temporarily
    • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
    • if solution changes color or become cloudy, do not use
    • overuse may produce increased redness of the eye
    • remove contact lens before using

    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

    If pregnant or breast-feeding

    ask a healthcare professional before use

    Keep out of reach of children

    If accidentally swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

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

  • Other information

    Store at 15 o- 30 oC (59 o- 86 oF)

  • Inactive Ingredients

    benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT 
    dextran, polyethylene glycol 400, povidone, tetrahydrozoline solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-697
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 700.1 g  in 100 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4001 g  in 100 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE1 g  in 100 mL
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    BORIC ACID (UNII: R57ZHV85D4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-697-291 in 1 CARTON03/01/2007
    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 DrugM01803/01/2007
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(49348-697) , pack(49348-697) , label(49348-697)
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