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

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.

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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 finalpart34904/16/2018
Labeler - MEDTECH PRODUCTS INC (114707784)
Establishment
NameAddressID/FEIBusiness Operations
Akorn AG482198285analysis(58790-007) , label(58790-007) , manufacture(58790-007) , pack(58790-007)

Revised: 3/2022
Document Id: bdf0c6be-3cf1-43ba-a7ac-c3e8aa02024e
Set id: 77f504c1-b8e0-4371-ac3e-9d453d84714b
Version: 4
Effective Time: 20220308
 
MEDTECH PRODUCTS INC