Label: THERATEARS- carboxymethylcellulose sodium gel

  • NDC Code(s): 58790-002-28, 58790-003-30
  • Packager: MEDTECH PRODUCTS 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 March 22, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (In each unit dose)

    sodium carboxymethylcellulose 1%

  • 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 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 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 or comments?        1-800-579-8327

  • Principal Display Panel Text for Carton Label:

    PRESERVATIVE

    FREE

    RECOMMENDED

    DOCTOR

    CREATED

    thera

    tears®

    THERAPY FOR YOUR EYES®

    Liquid Gel

    nighttime

    dry eye therapy

    LUBRICANT EYE GEL

    SOOTHING

    OVERNIGHT

    RELIEF

    30 STERILE

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

    PRESERVATIVE FREE RECOMMENDED DOCTOR CREATED thera tears® THERAPY FOR YOUR EYES® Liquid Gel nighttime dry eye therapy LUBRICANT EYE GEL SOOTHING OVERNIGHT RELIEF 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®

    Liquid Gel

    nighttime

    dry eye therapy

    LUBRICANT EYE GEL

    SOOTHING

    OVERNIGHT

    RELIEF

    4 Single-Use Vials 0.08 FL OZ (2.4 mL) TOTAL

    PRESERVATIVE FREE RECOMMENDED DOCTOR CREATED thera tears® THERAPY FOR YOUR EYES® Liquid Gel nighttime dry eye therapy LUBRICANT EYE GEL SOOTHING OVERNIGHT RELIEF 4 Single-Use Vials 0.08 FL OZ (2.4 mL) TOTAL

  • INGREDIENTS AND APPEARANCE
    THERATEARS 
    carboxymethylcellulose sodium gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-002
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X) carboxymethylcellulose sodium, unspecified form10 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:58790-002-287 in 1 CARTON12/01/2002
    10.6 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/01/2002
    THERATEARS 
    carboxymethylcellulose sodium gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-003
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X) carboxymethylcellulose sodium, unspecified form10 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:58790-003-306 in 1 CARTON12/07/2018
    15 in 1 POUCH
    10.6 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/07/2018
    Labeler - MEDTECH PRODUCTS INC (114707784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoire Unither574139809label(58790-002, 58790-003) , manufacture(58790-002, 58790-003) , pack(58790-002, 58790-003)
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