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Family Care Advanced Formula Eye (United Exchange Corp)

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SOLUTION/ DROPS 1 BOTTLE in 1 CARTON (65923-511-15) > 15 mL in 1 BOTTLE Label Information

Complete Family Care Advanced Formula Eye Information

  • ACTIVE INGREDIENT

    Active ingredients                                                                            Purpose

    Tetrahydrozoline HCl 0.05%.............................................................Redness reliever

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

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

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


  • 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

    For external use only


  • PURPOSE

    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 Poison 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

  • OTHER SAFETY INFORMATION

    Other information

    • some users may experience a brief tingling sensation
    • store at 15° to 25°C (59° to 77°F)

  • INACTIVE INGREDIENT

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


  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave,

    Cerritos, CA 90703 USA

    Made in Korea


  • INGREDIENTS AND APPEARANCE
    FAMILY CARE ADVANCED FORMULA EYE 
    tetrahydrozoline hydrochloride, dextran 70, polyethylene glycol 400, povidone solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-511
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg  in 1 mL
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 70 1 mg  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 10 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65923-511-15 1 in 1 CARTON 11/25/2014
    1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 11/25/2014
    Labeler - United Exchange Corp (840130579)