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

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REAL (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [OLIVER LANDON INTL INC.]
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NDC 59276-403-05, 59276-403-30
Set ID 580474a2-d640-49cf-b50c-c83420e52e1a
Category HUMAN OTC DRUG LABEL
Packager Oliver Landon Intl Inc.
Generic Name
Product Class
Product Number
Application Number PART349
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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 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.

  • 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.

  • 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 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

    Real Lubricant Eye Drops label

    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

  • 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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