Label: LEADER LUBRICATING EYE- carboxymethylcellulose sodium, and glycerin 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 December 23, 2014

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  • ACTIVE INGREDIENT

    Active ingredients                                                           Purpose

    Carboxymethylcellulose Sodium 0.5%----------------------- Lubricant

    Glycerin 0.9%------------------------------------------------- Lubricnat

  • PURPOSE

    Uses

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

    Warnings

    • For external use only
  • WHEN USING

    When using this product

    • To avoid contamination, do not touch tip of container to any surface.  Replace cap after using.
    • Do not use if solution changes color or gets cloudy.
  • STOP USE

    Stop use and ask a doctor if

    You feel eye pain, changes in vision, continued redness, or irritation of the eye, or if the condition worsens or persists for 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 immediately.

  • INDICATIONS & USAGE

    Directions

    Put 1 or 2 drops in the affected eye(s) as needed.

  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, boric acid, calcium chloride dihydrate, erythritol, levocarnitine, magnesium chloride, potassium chloride, purified water, sodium borate, sodium citrate dihydrate

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    CIN 4290763

    www.myleader.com

    1-800-200-6313

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LEADER LUBRICATING EYE 
    carboxymethylcellulose sodium, and glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-635
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM5 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORATE DIHYDRATE (UNII: BBB2RG413E)  
    ERYTHRITOL (UNII: RA96B954X6)  
    LEVOCARNITINE (UNII: 0G389FZZ9M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-635-051 in 1 CARTON
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/04/2012
    Labeler - CARDINAL HEALTH (097537435)
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