Label: LEADER DRY EYE RELIEF- dextran 70 solution

  • 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 July 12, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients                                                                          Purpose

    Dextran 70 (0.1%).........................................................................(Lubricant)

    Hypromellose 2910 (0.3%).............................................................(Lubricant)

  • PURPOSE

    Uses

    • for the temporary relief of burning 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

    For external use only. Do not use: If this solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

  • WHEN USING

    When using this product

    • remove contact lenses before using
    • 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 pain
    • changes in vision occur
    • redness or irritation of the eye gets worse 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) as needed.
    • Store at room temperature
  • INACTIVE INGREDIENT

    Inactive Ingredients: Benzalkonium Chloride, Potassium Chloride, Disodium Chloride, Sodium Borate, Sodium Chloride, Boric Acid, Sterile Water, Purified Water, Sodium Chloride, and Sodium Citrate

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    LEADER DRY EYE RELIEF 
    dextran 70 solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-9637
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 700.001 mL  in 1 mL
    HYPROMELLOSE 2910 (4000 CPS) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 CPS) - UNII:RN3152OP35) HYPROMELLOSE 2910 (4000 CPS)0.003 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BORIC ACID (UNII: R57ZHV85D4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11716-9637-71 in 1 CARTON
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/12/2010
    Labeler - HANLIM PHARM. CO., LTD. (687986034)
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