Label: ARTIFICIAL TEARS- 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 April 1, 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 of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • 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

    Lubricant Eye Drops

    Refresh, Lubricate and Moisturizes

    Distributed by.

    ARU PHARMA INC.

    MOUNT VERNON, NY 10552

    www.qpackrx.com

  • Packaging

    Artfdrp

  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70403-921
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM10 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:70403-921-151 in 1 CARTON01/22/2018
    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 finalpart34901/22/2018
    Labeler - Aru Pharma Inc. (079736192)