Label: CARBOXYMETHYLCELLULOSE SODIUM OPHTHALMIC SOLUTION 0.5%- carboxymethylcellulose sodium solution/ drops

  • 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 January 31, 2022

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  • Active ingredient

    Carboxymethylcellulose sodium 0.5%

  • Purpose

    Eye Lubricant

  • Use

    • 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 protectant against further irritation.

  • Warnings

    For use in the eyes only

  • Do not use

    • If solution changes color or becomes cloudy.

  • When using this product

    • Avoid contamination, do not touch tip of container to any surface.
    • Replace cap after use.

  • Stop use and ask a doctor if

    • You experience eye pain, changes in vision, continued redness or irritation of the eye.
    • The condition worsens or persists for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of the children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

  • Directions

    • Shake well before use.
    • Instill 1 or 2 drops in the affected eye(s) as needed.

  • Other Information

    • Store at room temperature 15°- 30 ° (59 °- 86 °F).
    • Do Not Use if imprinted seal on cap is torn, broken or missing.
    • Discard 90 days after opening
    • Retain outer carton for full product drug information

  • Inactive Ingredient

    Boric Acid, Calcium Chloride, Magnesium Chloride, Potassium Chloride, Purified water, Sodium borate, Sodium Chloride. Stabilized Oxychloro Complex 2.5%. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions or Comments?

    • 1-855-317-1107

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    EMC Pharma, LLC
    11551 Adie Rd, Maryland Heights, MO 63043

    Rev. 10/2021

  • PRINCIPAL DISPLAY PANEL

    Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (NDC 81288-798-15)

    image description

  • INGREDIENTS AND APPEARANCE
    CARBOXYMETHYLCELLULOSE SODIUM OPHTHALMIC SOLUTION 0.5% 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81288-798
    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
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    Magnesium Chloride (UNII: 02F3473H9O)  
    Potassium Chloride (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    Sodium borate (UNII: 91MBZ8H3QO)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81288-798-151 in 1 CARTON01/01/2022
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/01/2022
    Labeler - EMC Pharma, LLC (117754047)
    Registrant - EMC Pharma, LLC (117754047)
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