WALGREENS STERILE ADVANCE RELIEF EYE DROPS (DEXTRAN, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WALGREEN COMPANY]

WALGREENS STERILE ADVANCE RELIEF EYE DROPS (DEXTRAN, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WALGREEN COMPANY]
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NDC 0363-1677-15
Set ID 138b8a7c-99f5-45e6-a81b-fbb211e1c99d
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Active Ingredients                                                 Purpose

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

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

    Tetrahydrozoline HCI 0.05%................................. Redness Reliever

  • PURPOSE

    Uses

    • for the relief of redness of the eyes due to minor eye irritations
    • for use as a protection 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 persists
    • 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 Poision Control Center right away

  • INDICATIONS & USAGE

    Directions

    • To open bottle, push cap down and twist counter-clockwise. 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 tangling sensation
    • store at 15° to 25°C (59° to 77°F)

  • INACTIVE INGREDIENT

    Inactive Ingredients:

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

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    WALGREEN CO.

    200 WILMOT RD.

    DEERFIELD, IL 60015

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WALGREENS STERILE ADVANCE RELIEF EYE DROPS 
    dextran, polyethylene glycol, povidone, tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1677
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 70.001 mg  in 1 mg
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400.01 mg  in 1 mg
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE.01 mg  in 1 mg
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE.0005 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1677-151 in 1 BOX
    115 mg in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/25/2014
    Labeler - Walgreen Company (008965063)

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