EYS-ED (CARBOXYMETHYLCELLULOSE SODIUM 0.5%) SOLUTION/ DROPS [EYES-PLUS LLC]

EYS-ED (CARBOXYMETHYLCELLULOSE SODIUM 0.5%) SOLUTION/ DROPS [EYES-PLUS LLC]
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NDC 57349-397-04
Set ID 6e8d6f5a-4d55-66e8-e053-2991aa0a553c
Category HUMAN OTC DRUG LABEL
Packager Eyes-Plus LLC
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Carboxymethylcellulose sodium 0.5%...............Eye lubricant

  • PURPOSE

    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

    • To avoid contamination, do not touch tip of container to any surface.
    • Do not reuse. Once opened, discard.
    • Do not touch unit does tip to eye.
    • If solution changes color or becomes cloudy, do not use.
  • STOP 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 condtion worsens or persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    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., SILAS) 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° to 86°F (15° to 30°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.

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Eys Plus LLC

    Lomita, CA 90717'

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    eysplus

  • INGREDIENTS AND APPEARANCE
    EYS-ED 
    carboxymethylcellulose sodium 0.5% solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57349-397
    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
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57349-397-045 in 1 BOX06/13/2018
    10.4 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34906/13/2018
    Labeler - Eyes-Plus LLC (078751656)
    Registrant - Eyes-Plus LLC (078751656)

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