Label: LEADER LUBRICANT EYE DROPS 30CT- polyethylene glycol 400, propylene glycol liquid

  • NDC Code(s): 55651-017-01
  • Packager: KC Pharmaceuticals, Inc.
  • 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 February 22, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredients

    Polyethylene glycol 400 0.4%

    Propylene glycol 0.3%

  • Purposes

    Lubricant

    Lubricant

  • Use

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

    For external use only

    Do not use

    • if the solution changes color or becomes cloudy
    • if you are sensative to any ingredient in this product

    When using this product

    • do not touch 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 or lasts more than 72 hours

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    • instill 1 or 2 drops in the affected eye(s) as needed
  • 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 ingredients

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

  • Questions or comments?

    Call 1-888-527-4276

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    LEADER LUBRICANT EYE DROPS 30CT 
    polyethylene glycol 400, propylene glycol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55651-017
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL, UNSPECIFIED - UNII:3WJQ0SDW1A) 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
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    BORIC ACID (UNII: R57ZHV85D4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55651-017-0130 in 1 BOX07/18/2019
    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 finalpart34907/18/2019
    Labeler - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.C. Pharmaceuticals, Inc.174450460pack(55651-017) , label(55651-017)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed689852052manufacture(55651-017)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!