Label: GENTLE EYES LUBRICANT EYE DROPS- carboxymethylcellulose sodium solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 18, 2024

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  • Active ingredient

    Carboxymethylcellulose sodium 0.5%

  • 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 eyes only.
    • Retain outer carton for full product drug facts.

    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 out of reach of children.If swallowed, get medical help or contact a Poison Control Center right awav.

    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.

    If pregnant or breast feeding

    • If pregnant or breast feeding, ask a health professional before use.
  • Directions

    • Wash your hands.
    • Instill 1 or 2 drops in the affected eye(s) as needed.
  • Other information

    • Store at room temperature 15°-30°C (59°-86°F).
    • Keep tightly closed.
    • EXPIRATION DATE ONLY REFERS TO THE UNOPENED BOTTLE.
    • The use of this container by more than one person may spread infection.
  • Inactive ingredients

    Boric acid, Calcium| chloride, Hydrochloric acid*, Magnesium chloride, Potassium chloride, Purified water, Sodium borate, Sodium chloride, Sodium hydroxide*. Stabilized axychloro complex 2.5%.

    *May contain one or more of these ingredients to adjust pH.

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  • PRINCIPAL DISPLAY PANEL

    Carton

    Label

  • INGREDIENTS AND APPEARANCE
    GENTLE EYES LUBRICANT EYE DROPS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17312-430
    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 CHLORITE (UNII: G538EBV4VF)  
    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:17312-430-151 in 1 CARTON03/18/2024
    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 DrugM01803/18/2024
    Labeler - TRP Company (105185719)
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