Label: LEADER LUBRICATING PLUS- 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 April 17, 2018

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  • Active ingredient (in each single-use container)

    Carboxymethylcellulose sodium 0.5%

  • Purpose

    Eye lubricant

  • 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

  • Do not use

    if solution changes color or becomes cloudy

  • When using this product

    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
  • 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 reach of children.

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

  • Directions

    •
    to open, twist and pull tab to remove
    •
    instill 1 or 2 drops in the affected eye(s) as needed and discard container
  • Other information

    •
    store at 20-25°C (68-77°F)
    •
    RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • Inactive ingredients

    calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium lactate solution, water for injection. May also contain sodium hydroxide and/or hydrochloric acid to adjust pH.

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Sterile

    Lubricating Plus

    Carboxymethylcellulose Sodium 0.5%

    Lubricant Eye Drops

    Actual Size

    COMPARE TO REFRESH PLUS®

    active ingredient

    100% Money Back Guarantee

    Moisturizing Relief

    Preservative Free

    30 STERILE SINGLE-USE VIALS

    0.01 FL OZ (0.4 mL) EACH

    lubricating-plus-image

  • INGREDIENTS AND APPEARANCE
    LEADER LUBRICATING PLUS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0352
    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)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0352-130 in 1 CARTON04/17/2018
    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 finalpart34904/17/2018
    Labeler - Cardinal Health (097537435)
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