Label: LEADER RESTORATIVE FORMULA LUBRICANT EYE DROPS- propylene glycol solution/ drops

  • NDC Code(s): 70000-0013-1, 70000-0013-2
  • Packager: Cardinal Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2023

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  • ACTIVE INGREDIENT

    Active ingredients

    Propylene glycol....0.6%

  • PURPOSE

    Purpose

    Propylene glycol............ Lubricant

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings
    For external use only

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

    When using this product
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each 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, persists 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 (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Shake well before using.
    • Instill 1 or 2 drops in the affected eye(s) as needed
  • OTHER SAFETY INFORMATION

    Other information

    • Store at room temperature.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Benzalkonium chloride, boric acid, castor oil, disodium edetate hydrate, polyoxyethylene sorbitan monooleate, potassium chloride, purified water, sodium borate, sodium chloride.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • QUESTIONS

    Questions & comments?

    1-888-527-4276

  • PRINCIPAL DISPLAY PANEL

    carton-single pack

  • PRINCIPAL DISPLAY PANEL

    carton-twin pack

  • INGREDIENTS AND APPEARANCE
    LEADER RESTORATIVE FORMULA LUBRICANT EYE DROPS 
    propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0013
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0013-11 in 1 BOX04/30/2019
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:70000-0013-22 in 1 BOX04/30/2019
    215 mL in 1 BOTTLE, DROPPER; 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 - Daewoo Pharmaceutical Co., Ltd. (689046329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daewoo Pharmaceutical Co., Ltd.689046329manufacture(70000-0013) , pack(70000-0013) , label(70000-0013)
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