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

  • 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 contamination, do not touch tip of opened container to any surface.
      Do not reuse. Once opened discard. Use individual vials within 90 days of opening foil pouch.
    • This product contains no preservatives. Any solution not used immediately after opening should he discarded. Re-use of this single-use product may lead to inflammation of the eye and/or discomfort, based on potential contamination during handling.

    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

    • To open, twist tab completely off.
    • Instill 1 or 2 drops of TheraTears® EXTRA® in the affected eye(s) as needed
  • Other information

    • Use only if foil pouch is sealed and single-use container is intact.
    • Do not touch unit-dose tip to eye.
  • Inactive ingredients

    Boric acid, calcium chloride, hydrochloric acid*, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium hydroxide*, sodium phosphate, trehalose, and water for injection. *May contain these ingredients to adjust pH.

  • Questions or comments?

    1-800-579-8327

  • Principal Display Panel Text for Carton Label:

    PRESERVATIVE

    FREE

    RECOMMENDED

    DOCTOR

    CREATED

    thera

    tears®

    THERAPY FOR YOUR EYES®

    EXTRA®

    dry eye therapy

    LUBRICANT

    EYE DROPS

    EXTRA MOISTURIZING

    √ Rehydrates

    √ Protects

    √ Supports pH Level

    30 STERILE

    Single-Use Vials 0.60 FL OZ (18.0 mL) TOTAL

    Principal Display Panel Text for Carton Label: PRESERVATIVE FREE RECOMMENDED DOCTOR CREATED thera tears® THERAPY FOR YOUR EYES® EXTRA® dry eye therapy LUBRICANT EYE DROPS EXTRA MOISTURIZING √ Rehydrates √ Protects √ Supports pH Level 30 STERILE Single-Use Vials 0.60 FL OZ (18.0 mL) TOTAL

  • INGREDIENTS AND APPEARANCE
    THERATEARS EXTRA 
    carboxymethylcellulose sodium, unspecified solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-010
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311) (Carboxymethylcellulose - UNII:05JZI7B19X) Carboxymethylcellulose Sodium, Unspecified2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Boric Acid (UNII: R57ZHV85D4)  
    calcium chloride (UNII: M4I0D6VV5M)  
    hydrochloric acid (UNII: QTT17582CB)  
    magnesium chloride (UNII: 02F3473H9O)  
    potassium chloride (UNII: 660YQ98I10)  
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    sodium borate (UNII: 91MBZ8H3QO)  
    sodium chloride (UNII: 451W47IQ8X)  
    sodium hydroxide (UNII: 55X04QC32I)  
    sodium phosphate (UNII: SE337SVY37)  
    trehalose (UNII: B8WCK70T7I)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58790-010-306 in 1 CARTON01/21/2021
    15 in 1 POUCH
    10.6 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 DrugM01801/21/2021
    Labeler - MEDTECH PRODUCTS INC (114707784)
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