Label: GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER- dextran, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution

  • NDC Code(s): 50804-130-01
  • Packager: Geiss, Derstin & Dunn, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Dextran 70.....0.1%

    Polyethylene glycol 400.....1%

    Povidone.....1%

    tetrahydrozoline HCl.....0.05%

  • PURPOSE

    Purposes

    Dextran 70.....Lubricant

    Polyethylene glycol 400.....Lubricant

    Povidone.....Lubricant

    Tetrahydrozoline HCl .....Redness reliever

  • INDICATIONS & USAGE

    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

    Warnings

    For external use only

    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, or if the condition worsens or persists for more than 72 hours

    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 changed color or becomes cloudy, do not use
    • overuse may produce increased redness of the eye
    • remove contact lens before using

    If pregnant or breast-feeding , ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison control Center (1-800-111-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

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

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER 
    dextran, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-130
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4001 g  in 100 mL
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE1 g  in 100 mL
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 700.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-130-011 in 1 CARTON01/02/2020
    115 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01801/02/2020
    Labeler - Geiss, Derstin & Dunn, Inc. (076059836)
    Registrant - K.C. Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.C. Pharmaceuticals, Inc.174450460manufacture(50804-130) , pack(50804-130) , label(50804-130)
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