Label: REAL- 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 December 5, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Carboxymethylcellulose sodium 0.5%

  • PURPOSE

    Purpose

    Eye Lubricant

  • INDICATIONS & USAGE

    Use

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

    If pregnant or breast-feeding, ask a doctor before use.

    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 only if single-use container is intact
    • Use before expiration date marked on container
    • Store at 59°-86°F (15°-33°C)
    • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • 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 or Comments?

    info@oliverlandon.biz

  • PRINCIPAL DISPLAY PANEL

    NDC 59276-403-05

    Real
    Lubricant Eye Drops

    • Moisturizing relief
    • Immediate, soothing relief for dry eyes.

    Preservative-free

    Directions
    To open, TWIST AND PULL TAB TO REMOVE

    Instill 1 or 2 drops in the affected eye(s) as needed and discard container.
    5 Single-Use Containers
    0.01 fl oz (0.4 mL) each Sterile

    580474A2=D640-49CF-B50C-C83420E52E1A-00

  • INGREDIENTS AND APPEARANCE
    REAL 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59276-403
    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:59276-403-055 in 1 CARTON11/14/2018
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:59276-403-3030 in 1 CARTON11/14/2018
    20.4 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 finalpart34911/14/2018
    Labeler - Oliver Landon Intl Inc. (815240195)
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