Label: LEADER LUBRICANT EYE DROPS- polyethylene glycol 400 solution

  • Category: HUMAN OTC DRUG LABEL

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 April 28, 2010

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  • ACTIVE INGREDIENT

    Active ingredients-------------------------------------------------Purpose

    Polyethylene Glycol 400 (0.4%)-----------------------------Lubricant

    Propylene Glycol (0.3%)---------------------------------------Lubricant

  • PURPOSE

    Uses

    For the temporary relief of burning and irritation due to eye dryness.

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    • if solution changes color or becomes cloudy
    • if you are sensitive or allergic to any ingredient in this product
  • WHEN USING

    When using this product

    • 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 experience eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse or lasts more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • INDICATIONS & USAGE

    Directions

    • Put 1 or 2 drops in the affected eye/s as needed.
  • INACTIVE INGREDIENT

    Inactive ingredients: Boric Acid, Calcium Chloride, Chlorhexidine Gluconate, Hydrochloric Acid, Hydroxypropyl Guar,

    Magnesium Chloride, Potassium Chloride, Purified Water, Sodium Chloride, Zinc Chloride

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    LEADER LUBRICANT EYE DROPS 
    polyethylene glycol 400 solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-1192
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL - UNII:3WJQ0SDW1A) POLYETHYLENE GLYCOL 4000.4 mL  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.3 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11716-1192-61 in 1 CARTON
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34904/28/2010
    Labeler - HANLIM PHARM. CO., LTD. (687986034)
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