Label: CARBOXYMETHYLCELLULOSE SODIUM 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 August 27, 2009

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  • ACTIVE INGREDIENT

    Carboxymethylcellulose sodium (CMC) 0.5% ............... 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.
    • 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.
    • Do not use if solution changes color or becomes cloudy.
  • 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 than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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.

  • OTHER INFORMATION

    • Use only if single-use container is intact.
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • INACTIVE INGREDIENTS

    Calcium chloride; magnesium chloride; potassium chloride; purified water; sodium chloride; and sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 30 Sterile Single Use Containers


    CARBOXYMETHYLCELLULOSE SODIUM (CMC) 0.5%
    LUBRICANT EYE DROPS
     
    carboxymethylcellulose sodium
     
  • INGREDIENTS AND APPEARANCE
    CARBOXYMETHYLCELLULOSE SODIUM 
    carboxymethylcellulose sodium solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49668-001
    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:49668-001-0130 in 1 CONTAINER
    10.4 mL in 1 VIAL, SINGLE-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34910/01/2009
    Labeler - PROMED EXPORTS PRIVATE LIMITED (650538325)
    Establishment
    NameAddressID/FEIBusiness Operations
    PROMED EXPORTS PRIVATE LIMITED650538325manufacture
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