Label: LUBRICANT EYE DROPS PRESERVATIVE FREE 30 SINGLE USE CONTAINER- carboxymethylcellulose sodium liquid

  • 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 February 24, 2020

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  • Drug Facts

  • Active ingredients

    Carboxymethylcellulose sodium 0.5%

    Purposes

    Lubricant

  • Use

    • for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun
    • may be used as a protectant against further irritation
  • Warnings

    For external use only

    Do not use

    • solution changes color or becomes cloudy

    When using this product

    • do not reuse
    • once opened, discard
    • to avoid contamination, do not touch tip of container to any surface
    • do not touch unit-dose tip to eye

    Stop use and ask a doctor if

    • you experience eye pain
    • changes in vision occur
    • redness or irritation of the eye continues
    • redness or irritation of the eye worsens or persists for more than 72 hours

    Keep out of reach of children.

    If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • 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., LASIK) dryness and discomfort, follow your eye doctor’s instructions
  • Other information

    • store at 15°-25°C (59°-77°F)
    • use only if single-use container is intact
    • use before expiration date marked on container
    • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Inactive ingredients

    calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride and sodium lactate. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

  • Questions or comments?

    Call X-XXX-XXX-XXXX DAYS & TIMES & ZONE

  • Package Labeling:

    Label5

  • INGREDIENTS AND APPEARANCE
    LUBRICANT EYE DROPS PRESERVATIVE FREE 30 SINGLE USE CONTAINER 
    carboxymethylcellulose sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73450-002
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73450-002-0530 in 1 BOX04/20/2020
    10.5 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 finalpart34904/20/2020
    Labeler - Nexus Optical Inc (107289657)
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