Label: CARBOXYMETHYLCELLULOSE SODIUM- carboxymethylcellulose sodium solution

  • NDC Code(s): 49668-001-01
  • Packager: PROMED EXPORTS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/09

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Carboxymethylcellulose sodium (CMC) 0.5% ............... Eye lubricant

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  • 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.
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  • 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.
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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • 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.

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  • OTHER INFORMATION

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

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


    CARBOXYMETHYLCELLULOSE SODIUM (CMC) 0.5%
    LUBRICANT EYE DROPS

     
    carboxymethylcellulose sodium
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  • INGREDIENTS AND APPEARANCE
    CARBOXYMETHYLCELLULOSE SODIUM 
    carboxymethylcellulose sodium solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49668-001
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE) CARBOXYMETHYLCELLULOSE SODIUM 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM CHLORIDE  
    MAGNESIUM CHLORIDE  
    POTASSIUM CHLORIDE  
    WATER  
    SODIUM CHLORIDE  
    SODIUM LACTATE  
    HYDROCHLORIC ACID  
    SODIUM HYDROXIDE  
    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
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