Label: THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops

  • NDC Code(s): 58790-001-15, 58790-001-30, 58790-001-31
  • Packager: MEDTECH PRODUCTS INC
  • 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 8, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium carboxy-
    methylcellulose 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. Replace cap after using.

    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

    Instill 1 or 2 drops 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

    Borate buffers, calcium chloride, Dequest®, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride, sodium perborate, sodium phosphate, and water for injection.

  • Questions or comments?

    1-800-579-8327

  • Principal Display Panel Text for Carton Label:

    VALUE SIZE

    RECOMMENDED

    DOCTOR

    CREATED

    thera

    tears®

    THERAPY FOR YOUR EYES®

    dry eye therapy

    LUBRICANT

    EYE DROPS

    IMMEDIATE

    LONG LASTING

    RELIEF

    STERILE

    Multi-Use Bottle*

    1 FL OZ (30 mL)

    VALUE SIZE RECOMMENDED DOCTOR CREATED thera tears® THERAPY FOR YOUR EYES® dry eye therapy LUBRICANT EYE DROPS IMMEDIATE LONG LASTING RELIEF STERILE Multi-Use Bottle* 1 FL OZ (30 mL)

  • INGREDIENTS AND APPEARANCE
    THERATEARS LUBRICANT 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-001
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    carboxymethylcellulose sodium (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X) carboxymethylcellulose sodium2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    boric acid (UNII: R57ZHV85D4)  
    sodium perborate (UNII: Y52BK1W96C)  
    calcium chloride (UNII: M4I0D6VV5M)  
    diethylenetriamine pentamethylene phosphonic acid (UNII: 0Q75589TM3)  
    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:58790-001-301 in 1 CARTON07/01/1999
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:58790-001-151 in 1 CARTON07/01/1999
    215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:58790-001-312 in 1 CARTON12/01/2020
    330 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 finalpart34907/01/1999
    Labeler - MEDTECH PRODUCTS INC (114707784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn AG482198285analysis(58790-001) , label(58790-001) , manufacture(58790-001) , pack(58790-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn Operating Company LLC (dba Akorn)117696790label(58790-001) , pack(58790-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn Operating Company LLC (dba Akorn)117696832analysis(58790-001) , manufacture(58790-001) , sterilize(58790-001)
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