Label: LEADER PRESERVATIVE-FREE ULTRA LUBRICATING EYE DROPS- polyethylene glycol 400, propylene glycol solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2023

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  • ACTIVE INGREDIENT

    Active ingredients

    Polyethylene glycol 400  0.4%
    Propylene glycol   0.3%

  • PURPOSE

    Purpose

    Polyethylene glycol 400............. Lubricant
    Propylene glycol............ Lubricant

  • INDICATIONS & USAGE

    Uses
    • for the temporary relief of burning and irritation of the eye due to dryness of the eye

  • WARNINGS

    Warnings
    For external use only

    Do not use
    • if this product changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product

    When using this product
    • do not touch the tip of container to any surface to avoid contamination
    • do not reuse

    • once opened, discard

    Stop use and ask a doctor if
    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions
    • Instill 1 or 2 drops in the affected eye(s) as needed

  • OTHER SAFETY INFORMATION

    Other information

    • store at 15°-25°C (59°-77°F)
    • use only if single-use container is intact
    • use before expiration date marked on container
    • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • INACTIVE INGREDIENT

    Inactive ingredients

    boric acid, hypromellose, potassium chloride, purified water, sodium chloride.  May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

  • QUESTIONS

    Questions or comments?  Call 1-888-527-4276

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    LEADER PRESERVATIVE-FREE ULTRA LUBRICATING EYE DROPS 
    polyethylene glycol 400, propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0501
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.4 g  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0501-125 in 1 BOX04/30/2019
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01804/30/2019
    Labeler - Cardinal Health (063997360)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460pack(70000-0501) , label(70000-0501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed689852052manufacture(70000-0501)
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