Label: THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops

  • NDC Code(s): 58790-001-15, 58790-001-30, 58790-001-31
  • Packager: Advanced Vision Research (Subsidiary of Akorn, Inc.)
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated October 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium carboxy-
    methylcellulose 0.25%

  • Purpose

    Eye lubricant

  • Uses

    • As a lubricant to relieve dryness of the eye.
    • As a protectant against further irritation of the eye.
    • For temporary relief of burning, irritation, and discomfort including exposure to wind or sun.
  • Warnings

    For external use only

    • To avoid contamination do not touch tip of opened container to any surface. Replace cap after using.

    Do not use

    • 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.
    • Condition worsens or persists for more than 72 hours.

    Keep out of reach of children. If 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

    • Do not use if neck ring is broken or missing.
    • Discard 45 days after opening.
  • Inactive ingredients

    Borate buffers, calcium chloride, Dequest®, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride, sodium perborate, sodium phosphate, and water for injection.

  • Questions or comments?

    1-800-579-8327

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    thera

    tears®

    THERAPY FOR YOUR EYES®

    dry eye therapy

    LUBRICANT

    EYE DROPS

    STERILE

    1 FL OZ (30 mL)

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    VALUE SIZE

    RECOMMENDED

    DOCTOR

    CREATED

    thera

    tears®

    THERAPY FOR YOUR EYES®

    dry eye therapy

    LUBRICANT

    EYE DROPS

    IMMEDIATE

    LONG LASTING

    RELIEF

    STERILE

    Multi-Use Bottle*

    1 FL OZ (30 mL)

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    THERATEARS LUBRICANT 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-001
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    carboxymethylcellulose sodium (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X) carboxymethylcellulose sodium2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    boric acid (UNII: R57ZHV85D4)  
    sodium perborate (UNII: Y52BK1W96C)  
    calcium chloride (UNII: M4I0D6VV5M)  
    diethylenetriamine pentamethylene phosphonic acid (UNII: 0Q75589TM3)  
    magnesium chloride (UNII: 02F3473H9O)  
    potassium chloride (UNII: 660YQ98I10)  
    water (UNII: 059QF0KO0R)  
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    sodium chloride (UNII: 451W47IQ8X)  
    sodium phosphate (UNII: SE337SVY37)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58790-001-301 in 1 CARTON07/01/1999
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:58790-001-151 in 1 CARTON07/01/1999
    215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:58790-001-312 in 1 CARTON12/01/2020
    330 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 finalpart34907/01/1999
    Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (117696736)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, Inc117696790PACK(58790-001) , LABEL(58790-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, Inc117696832MANUFACTURE(58790-001) , ANALYSIS(58790-001) , STERILIZE(58790-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn AG482198285ANALYSIS(58790-001) , LABEL(58790-001) , MANUFACTURE(58790-001) , PACK(58790-001)