Label: CARBOXYMETHYLCELLULOSE SODIUM gel

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Carboxymethylcellulose sodium 1%

  • Purpose

    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 use in the eyes only.
    • To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
    • If solution changes color or becomes cloudy, do not use.

    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 this and all drugs out of the reach of 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

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

    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?

    1-855-361-3993

    Distributed by:
    AvKARE

    Pulaski, TN 38478

    Rev. 09/2020 AV 09/2020

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    CARBOXYMETHYLCELLULOSE SODIUM 
    carboxymethylcellulose sodium gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-066
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM10 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50268-066-151 in 1 CARTON11/18/2020
    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 DrugM01811/18/2020
    Labeler - AvPAK (832926666)
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