Label: GOODSENSE ADVANCED RELIEF EYE- dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride solution/ drops

  • 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 December 19, 2014

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  • ACTIVE INGREDIENT

    Active ingredients                                                                     Purpose

    Dextran 70 0.1% .................................................................. Lubricant

    Polyethylene glycol 400 1% .................................................... Lubricant

    Povidone 1% ........................................................................ Lubricant

    Tetrahydrozoline HCL 0.05% .................................................. Redness Reliever

  • PURPOSE

    Uses

    • for the relief of redness of the eyes due to minor eye irritations
    • for use as a protectant against further irritation or to relieve dryness of the eye
  • WARNINGS

    Warnings

    Ask a doctor before use if you have narrow angle glaucoma

  • WHEN USING

    When using this product

    • pupils may become enlarged temporarily
    • overuse may cause more eye redness
    • remove contact lenses before using
    • do not use if this solution changes color or becomes cloudy
    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after each use
  • STOP USE

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition worsens or lasts more than 72 hours
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

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

  • INDICATIONS & USAGE

    Directions

    • to open bottle, push cap down and twist counterclockwise. To close bottle, twist clockwise until it stops turning
    • put 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • some users may experience a brief tingling
    • store at 15o to 25oC (59o to 77oF)
  • INACTIVE INGREDIENT

    Inactive ingredients:

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

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Geiss, Destin & Dunn, Inc.

    Peachtree City, GA 30269

    www.valuelabels.com

    1-866-696-0957

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    GOODSENSE ADVANCED RELIEF EYE 
    dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-0004
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE10 mg  in 1 mL
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11716-0004-91 in 1 CARTON
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34908/04/2010
    Labeler - HANLIM PHARM. CO., LTD. (687986034)
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