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

  • Category: HUMAN OTC DRUG LABEL

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 March 22, 2022

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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 finalpart34901/21/2021
    Labeler - MEDTECH PRODUCTS INC (114707784)
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