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Carboxymethylcellulose sodium (PROMED EXPORTS PRIVATE LIMITED)

Available Formats

Dosage Form Package Information Links
SOLUTION 30 VIAL, SINGLE-DOSE in 1 CONTAINER (49668-001-01) > .4 mL in 1 VIAL, SINGLE-DOSE Label Information

Complete Carboxymethylcellulose sodium Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:49668-001
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49668-001-01 30 in 1 CONTAINER
    1 0.4 mL in 1 VIAL, SINGLE-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part349 10/01/2009
    Labeler - PROMED EXPORTS PRIVATE LIMITED (650538325)
    Establishment
    Name Address ID/FEI Business Operations
    PROMED EXPORTS PRIVATE LIMITED 650538325 manufacture