Label: THERATEARS EXTRA- carboxymethylcellulose sodium, unspecified form solution/ drops

  • NDC Code(s): 58790-007-15, 58790-007-16
  • Packager: MEDTECH PRODUCTS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium carboxymethylcellulose 0.25%

  • Purpose

    Eye lubricant

  • Uses

    • For use as a protectant against further irritation or to relieve dryness of the eye.
    • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
  • Warnings

    For external use only

    • To avoid risk of contamination do not touch tip of opened container to any surface. Replace cap tightly after each use.

    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 right away.

  • Directions

    Instill 1 or 2 drops of TheraTears® Extra® 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

    Boric acid, calcium chloride, Dequest®, 2060S phosphonate, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium perborate, sodium phosphate, trehalose, and water for injection.

  • Questions or comments?

    1-800-579-8327

  • Principal Display Panel Text for Container Label:

    thera

    tears®

    THERAPY FOR YOUR EYES®

    EXTRA®

    dry eye therapy

    LUBRICANT

    EYE DROPS

    EXTRA MOISTURIZING

    √ Rehydrates

    √ Protects

    √ Supports pH Level

    STERILE

    Multi-Use

    Bottle TWO 0.5 FL OZ (15 mL) BOTTLES

    thera tears® THERAPY FOR YOUR EYES® EXTRA® dry eye therapy LUBRICANT EYE DROPS EXTRA MOISTURIZING √ Rehydrates √ Protects √ Supports pH Level STERILE Multi-Use Bottle TWO 0.5 FL OZ (15 mL) BOTTLES

  • Principal Display Panel Text for Carton Label:

    RECOMMENDED

    DOCTOR

    CREATED

    thera

    tears®

    THERAPY FOR YOUR EYES®

    EXTRA®

    dry eye therapy

    LUBRICANT

    EYE DROPS

    EXTRA MOISTURIZING

    √ Rehydrates

    √ Protects

    √ Supports pH Level

    STERILE

    Multi-Use

    Bottle 0.5 FL OZ (15 mL)

    RECOMMENDED DOCTOR CREATED thera tears® THERAPY FOR YOUR EYES® EXTRA® dry eye therapy LUBRICANT EYE DROPS EXTRA MOISTURIZING √ Rehydrates √ Protects √ Supports pH Level STERILE Multi-Use Bottle 0.5 FL OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    THERATEARS EXTRA 
    carboxymethylcellulose sodium, unspecified form solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-007
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311) (Carboxymethylcellulose - UNII:05JZI7B19X) Carboxymethylcellulose Sodium, Unspecified Form2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Boric Acid (UNII: R57ZHV85D4)  
    calcium chloride (UNII: M4I0D6VV5M)  
    Diethylenetriamine Pentamethylene Phosphonic Acid (UNII: 0Q75589TM3)  
    potassium chloride (UNII: 660YQ98I10)  
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    sodium borate (UNII: 91MBZ8H3QO)  
    sodium chloride (UNII: 451W47IQ8X)  
    magnesium chloride (UNII: 02F3473H9O)  
    sodium perborate (UNII: Y52BK1W96C)  
    sodium phosphate (UNII: SE337SVY37)  
    trehalose (UNII: B8WCK70T7I)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58790-007-151 in 1 CARTON04/16/2018
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:58790-007-162 in 1 CARTON12/01/2020
    215 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 DrugM01804/16/2018
    Labeler - MEDTECH PRODUCTS INC (114707784)
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