THERATEARS EXTRA- carboxymethylcellulose sodium, unspecified form solution/ drops 
MEDTECH PRODUCTS INC

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TheraTears Extra MD 58790-007

Drug Facts

Active ingredient

Sodium carboxymethylcellulose 0.25%

Purpose

Eye lubricant

Uses

Warnings

For external use only

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

Instill 1 or 2 drops of TheraTears® Extra® in the affected eye(s) as needed.

Other information

Inactive ingredients

Boric acid, calcium chloride, Dequest®, 2060S phosphonate, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium perborate, sodium phosphate, trehalose, and water for injection.

Questions or comments?

1-800-579-8327

Principal Display Panel Text for Container Label:

thera

tears®

THERAPY FOR YOUR EYES®

EXTRA®

dry eye therapy

LUBRICANT

EYE DROPS

EXTRA MOISTURIZING

 Rehydrates

 Protects

 Supports pH Level

STERILE

Multi-Use

Bottle TWO 0.5 FL OZ (15 mL) BOTTLES

thera
tears®
THERAPY FOR YOUR EYES®
EXTRA®
dry eye therapy
LUBRICANT
EYE DROPS
EXTRA MOISTURIZING
√ Rehydrates
√ Protects
√ Supports pH Level
STERILE
Multi-Use
Bottle TWO 0.5 FL OZ (15 mL) BOTTLES

Principal Display Panel Text for Carton Label:

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

EXTRA®

dry eye therapy

LUBRICANT

EYE DROPS

EXTRA MOISTURIZING

 Rehydrates

 Protects

 Supports pH Level

STERILE

Multi-Use

Bottle 0.5 FL OZ (15 mL)

RECOMMENDED
DOCTOR
CREATED
thera
tears®
THERAPY FOR YOUR EYES®
EXTRA®
dry eye therapy
LUBRICANT
EYE DROPS
EXTRA MOISTURIZING
√ Rehydrates
√ Protects
√ Supports pH Level
STERILE
Multi-Use
Bottle 0.5 FL OZ (15 mL)

THERATEARS EXTRA 
carboxymethylcellulose sodium, unspecified form solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-007
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)  
calcium chloride (UNII: M4I0D6VV5M)  
Diethylenetriamine Pentamethylene Phosphonic Acid (UNII: 0Q75589TM3)  
potassium chloride (UNII: 660YQ98I10)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
sodium borate (UNII: 91MBZ8H3QO)  
sodium chloride (UNII: 451W47IQ8X)  
magnesium chloride (UNII: 02F3473H9O)  
sodium perborate (UNII: Y52BK1W96C)  
sodium phosphate (UNII: SE337SVY37)  
trehalose (UNII: B8WCK70T7I)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58790-007-151 in 1 CARTON04/16/2018
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:58790-007-162 in 1 CARTON12/01/2020
215 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 DrugM01804/16/2018
Labeler - MEDTECH PRODUCTS INC (114707784)

Revised: 12/2024
Document Id: bf94724f-8ab9-45c2-855f-b7f37e3d6504
Set id: 77f504c1-b8e0-4371-ac3e-9d453d84714b
Version: 5
Effective Time: 20241213
 
MEDTECH PRODUCTS INC