Label: QUALITY CHOICE LUBRICATING EYE DROPS- carboxymethylcellulose sodium, glycerin solution

  • 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 September 30, 2012

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  • ACTIVE INGREDIENT

    Active ingredients------------------------------------------------Purpose

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

    Glycerin 0.9%-----------------------------------------------------Lubricant

  • PURPOSE

    Uses

    • For the temporary relief of burning, irritation and discomfort due to dryness of the eye or from irritation from wind or sun.
  • 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.

  • STORAGE AND HANDLING

    Other information

    • some users may experience a brief tingling sensation
    • Store at room temperature.
  • INACTIVE INGREDIENT

    Inactive ingredients:

    Boric Acid, Sodium Borate, Levocarnitin, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride, Erythritol, Sodium Citrate Dihydrate, Potassium Sorbate, Purified Water

  • DOSAGE & ADMINISTRATION

    Distributed by C.D.M.A., Inc.

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE LUBRICATING EYE DROPS 
    carboxymethylcellulose sodium, glycerin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-969
    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
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    LEVOCARNITINE (UNII: 0G389FZZ9M)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    ERYTHRITOL (UNII: RA96B954X6)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-969-151 in 1 CARTON
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/30/2012
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
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