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CARE ONE EYE DROPS SEASONAL RELIEF (HANLIM PHARM. CO., LTD.)

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SOLUTION 1 BOTTLE in 1 CARTON (11716-8653-3) > 15 mL in 1 BOTTLE Label Information

Complete CARE ONE EYE DROPS SEASONAL RELIEF Information

  • ACTIVE INGREDIENT

    Active Ingredients                                                               Purpose

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

    Zinc Sulfate 0.25% ............................................................Astringent


  • PURPOSE

    Uses

    • for the temporary relief of redness and irritation of the eye and for use as a protectant against further irritation.
    • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.

  • 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
    • do not touch tip of container to any surface to avoid contamination
    • 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

    • Instill 1 or 2 drops in the affected eye(s) up to 4 times daily
    • Store at 15 o to 25 oC (59 o to 77F o)
    • Children under  6 years of age: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients: Benzalkonium Chloride, Boric Acid, Edetate Disodium, Purified Water, Sodium Chloride, Sodium Citrate


  • DOSAGE & ADMINISTRATION

    Distributed By:

    American Sales Co.

    4201 Walden Ave.

    Lancaster, NY 14086


  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here


  • INGREDIENTS AND APPEARANCE
    CARE ONE EYE DROPS SEASONAL RELIEF 
    tetrahydrozoline hydrochloride and zinc sulfate solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11716-8653
    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
    ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE 2.5 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 CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11716-8653-3 1 in 1 CARTON 11/02/2010
    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 11/02/2010
    Labeler - HANLIM PHARM. CO., LTD. (687986034)
    Registrant - UNITED EXCHANGE CORP. (840130579)