Label: LEADER LUBRICANT EYE- carboxymethylcellulose sodium solution/ drops

  • 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 18, 2014

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  • ACTIVE INGREDIENT

    Active ingredient                                            Purpose

    Carboxymethylcellulose sodium 0.5%............. Eye lubricant

  • PURPOSE

    Uses

    • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
    • May be used as a protectant against further irritation.
  • WARNINGS

    For external use only.

    • To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.
    • Do not touch unit-dose tip to eye.
    • If solution changes color or becomes cloudy, do not use.
  • STOP USE

    Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more thatn 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poision Control Center right away.

  • INDICATIONS & USAGE

    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.
  • STORAGE AND HANDLING

    Other information

    • Use only if single-use container is intact.
    • Use before expiration date marked on container.
    • Store at 59°-86°F (15°-30°C)
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    CARDINAL HEALTH

    DUBLIN, OHIO 43017

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LEADER LUBRICANT EYE 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-032
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49781-032-301 in 1 BOX
    1.04 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/18/2014
    Labeler - Cardinal Health (097537435)
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