Label: GOODSENSE LUBRICATING EYE DROPS- carboxymethylcellulose sodium solution

  • Category: HUMAN OTC DRUG LABEL

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 July 30, 2010

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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.
    • May be sued 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: Boric Acid, Calcium Chloride Dihydrate, Chlorhexidine Gluconate, Erythritol Hexahydrate, Levocarnitine, Magnesium Chloride, Potassium Chloride, Purified Water, Sodium Borate Decahydrate, Sodium Citrate Dihydrate

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    GOODSENSE LUBRICATING EYE DROPS 
    carboxymethylcellulose sodium solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-0041
    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)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    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:11716-0041-81 in 1 CARTON
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/30/2010
    Labeler - HANLIM PHARM. CO., LTD. (687986034)
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