Label: LEADER LUBRICANT EYE DROPS- carboxymethylcellulose sodium liquid

  • NDC Code(s): 70000-0012-1, 70000-0012-2
  • Packager: Cardinal Health
  • 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 December 15, 2022

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

  • Active ingredients

    Carboxymethylcellulose sodium 0.5%

  • Purpose

    Lubricant

  • Uses

    • for the temoprary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun
    • may be used as a protectant against further irritation
  • Warnings

    For external use only

    Do not use this product if

    • solution changes color or becomes cloudy

    When using this product

    • do not reuse
    • once opened, discard
    • to avoid contamination, do not touch tip of container to any surface
    • do not touch unit-dose tip to eye

    Stop use and ask a doctor if

    • you experience eye pain
    • changes in vision occur
    • redness or irritation of the eye continues
    • redness or irritation of the eye worsens or persists for more than 72 hours

    Keep out of the reach of children.

    If accidentally swallowed, get medical help or contact a Poison Control Center (1800-222-1222) immediately.

  • Directions

    • to open, twist and pull tab to remove
    • instill 1 or 2 drops in the affected eye(s) as needed and discard container
    • if used for post-operative (e.g. LASIK) dryness and discomfort, follow your eye doctor's instructions
  • 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

    calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride and sodium lactate. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

  • Questions or comments?

    Call 1-888-527-4276

  • Leader Lubricant Eye Drops Preservative-Free 70 ct

    Leader Lubricant Eye Drops Preservative-Free 70 ct

  • INGREDIENTS AND APPEARANCE
    LEADER LUBRICANT EYE DROPS 
    carboxymethylcellulose sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0012
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0012-170 in 1 BOX07/13/2019
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:70000-0012-230 in 1 BOX07/13/2019
    20.4 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 finalpart34907/13/2019
    Labeler - Cardinal Health (063997360)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460pack(70000-0012) , label(70000-0012)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed689852052manufacture(70000-0012) , pack(70000-0012) , label(70000-0012)