Label: LUBRICANT EYE DROPS PRESERVATIVE FREE- 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 February 21, 2023

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  • ACTIVE INGREDIENT

    Active ingredient
    Carboxymethylcellulose sodium 0.5%

  • PURPOSE

    Purpose
    Carboxymethylcellulose sodium.............Lubricant

  • INDICATIONS & USAGE

    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

    ​Warnings

    For external use only.

    ​Do not use if solution changes color or becomes cloudy.

    When using the product

    • do not reuse
    • once opened, discard
    • to avoid contamination do not touch tip of container to any surface
    • do not touch unit-dose tip to eye.

    Stop use and ask a doctor if

    • you experience eye pain
    • changes in vision occur
    • redness or irritation of the eye continues
    • redness or irritation of the eye worsens or persists for more than 72 hours

    Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    Other information

    • Store at 15°-25°C (59°-77°F)
    • Use only if single-use container is intact
    • Use before expiration date marked on container
    • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • INACTIVE INGREDIENT

    Inactive ingredients
    Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium
    chloride, and sodium lactate. May contain sodium hydroxide and/or hydrochloric acid
    to adjust pH.

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    LUBRICANT EYE DROPS PRESERVATIVE FREE 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-150
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-150-0170 in 1 BOX02/12/2019
    10.4 mL in 1 VIAL, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/12/2019
    Labeler - Target Corporation (006961700)
    Registrant - Unimed (689852052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed689852052manufacture(11673-150)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460pack(11673-150) , label(11673-150)
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