Label: LUBRICANT EYE DROPS- 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 November 24, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Carboxymethylcellulose sodium 0.5%

  • PURPOSE

    Purpose

    Eye 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.
    • protects against further irritation.
  • WARNINGS

    Warnings

    For external use only

    Do not use if solution changes color or becomes cloudy

    When using this product

    • do not touch tip of container to any surface to avoid contamination.
    • do not reuse. Once opened, discard.

    Stop use and ask a doctor if

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

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

  • 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 dryness and discomfort, follow your eye doctor’s instructions.

  • STORAGE AND HANDLING

    Other information

    • use before expiration date marked on container.
    • store at 59°-86°F (15°-33°C)

    RETAIN THIS CARD FOR FUTURE REFERENCE.

    Use only if single-use container is intact.

  • INACTIVE INGREDIENT

    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.

  • QUESTIONS

    Questions & Comments? 1 (800) 839-5929

  • SPL UNCLASSIFIED SECTION

    Manufactured for: Oliver Landon Intl. Inc.

    The Grove, 21 Pine Road

    Belleville, St. Michael, BARBADOS BB11113

  • PRINCIPAL DISPLAY PANEL

    Lubricant Eye Drops
    0.4 ml (0.014 fl oz) per vial

    Lubricant Eye Drops vial label

  • INGREDIENTS AND APPEARANCE
    LUBRICANT EYE DROPS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59276-905
    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
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59276-905-055 in 1 CELLO PACK02/25/2019
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/25/2019
    Labeler - Oliver Landon Intl Inc. (815240195)
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