Label: ARTIFICIAL TEARS LUBRICANT EYE DROPS- 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 November 24, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Carboxymethylcellulose Sodium 10 MG in 1 ml.

  • Purpose

    Eye Lubricant

  • Uses

    • for use as a protectant against further irritation or to relieve dryness of the eye

    • for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

  • Warnings

    For external use only

    • Do not use this product if solution changes color or becomes cloudy

    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

    When using this product

    • to avoid contamination do not touch tip of container to any surface  • replace cap after using. Keep container tightly closed.

    • remove contact lens before using

    Keep out of the reach children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • Questions or comments?

    718-502-6610

    between 9 am and 4 pm EST, Monday - Friday.

  • Directions

    Instill 1 or 2 drops in the affected eye(s) as needed.

  • Other information

    • Tamper Evident. Do not use this product if neckband is missing or broken.

    • RETAIN THIS CARTON FOR FUTURE REFERENCE

    • Store at 15°-30°C (59°-86°F)

  • Inactive Ingredients

    Boric Acid

    Potassium Chloride

    Sodium Chloride

    Calcium Chloride Dihydrate.

    Magnesium Chloride

    Sodium Chlorite

    Sodium Hydroxide and 

    Water for Injection

  • SPL UNCLASSIFIED SECTION

    Compare to the active Ingredient in Refresh Plus Eye Drops

    Refresh, Lubricate and Moisturizes

    Distributed by.

    EzriCare, LLC

    Lakewood, NJ

    www.EzriCare.com

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS LUBRICANT EYE DROPS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79503-101
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    SODIUM CHLORITE (UNII: G538EBV4VF)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79503-101-151 in 1 CARTON11/22/2020
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/22/2020
    Labeler - Ezricare Llc (117573818)