Label: THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops

  • NDC Code(s): 58790-000-20, 58790-000-24, 58790-000-30, 58790-000-32
  • Packager: Advanced Vision Research (Subsidiary of Akorn, Inc.)
  • 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 October 8, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (In each unit dose)

    Sodium Carboxymethylcellulose 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. 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 be discarded. Re-use of this single-use product may lead to inflammation of the eye and/or discomfort, based on ptential 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 immediately.

  • Directions

    • To open, twist tab completely off.
    • Instill 1 or 2 drops 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

    Borate buffers, calcium chloride, magnesium chloride, potassium chloride, purified water, sodium bicarbonate, sodium chloride and sodium phosphate

  • Questions and comments?

    1-800-579-8327

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    PRESERVATIVE FREE

    thera

    tears®

    THERAPY FOR YOUR EYESTM

    dry eye therapy

    LUBRICANT

    EYE DROPS

    RESTORES EYES

    NATURAL BALANCE™

    4 Single-Use      STERILE

    Vials      0.08 FL OZ (2.4mL) TOTAL

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    PRESERVATIVE

    FREE

    RECOMMENDED

    DOCTOR

    CREATED

    thera

    tears®

    THERAPY FOR YOUR EYES®

    dry eye therapy

    LUBRICANT

    EYE DROPS

    IMMEDIATE

    LONG LASTING

    RELIEF

    32 STERILE

    Single-Use Vials*   0.65 FL OZ (19.2mL) TOTAL

    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:58790-000
    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)  
    sodium borate (UNII: 91MBZ8H3QO)  
    calcium chloride (UNII: M4I0D6VV5M)  
    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:58790-000-328 in 1 CARTON01/01/1995
    14 in 1 POUCH
    119.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:58790-000-246 in 1 CARTON01/01/1995
    24 in 1 POUCH
    219.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    3NDC:58790-000-205 in 1 CARTON01/01/1995
    34 in 1 POUCH
    319.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    4NDC:58790-000-305 in 1 CARTON12/07/2018
    46 in 1 POUCH
    40.6 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/01/1995
    Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (117696736)
    Registrant - Akorn Operating Company LLC (117693100)