LUBRICANT EYE DROPS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [OLIVER LANDON INTL INC.]

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LUBRICANT EYE DROPS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [OLIVER LANDON INTL INC.]
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NDC 59276-905-05
Set ID ec3160ac-a2d1-4132-a75a-4180b4bafdf3
Category HUMAN OTC DRUG LABEL
Packager Oliver Landon Intl Inc.
Generic Name
Product Class
Product Number
Application Number PART349
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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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