THERATEARS EXTRA- carboxymethylcellulose sodium, unspecified 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 PF 58790-010

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

Other information

Inactive ingredients

Boric acid, calcium chloride, hydrochloric acid*, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium hydroxide*, sodium phosphate, trehalose, and water for injection. *May contain these ingredients to adjust pH.

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®

EXTRA®

dry eye therapy

LUBRICANT

EYE DROPS

EXTRA MOISTURIZING

 Rehydrates

 Protects

 Supports pH Level

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®
EXTRA®
dry eye therapy
LUBRICANT
EYE DROPS
EXTRA MOISTURIZING
√ Rehydrates
√ Protects
√ Supports pH Level
30 STERILE
Single-Use Vials 0.60 FL OZ (18.0 mL) TOTAL

THERATEARS EXTRA 
carboxymethylcellulose sodium, unspecified solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-010
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311) (Carboxymethylcellulose - UNII:05JZI7B19X) Carboxymethylcellulose Sodium, Unspecified2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Boric Acid (UNII: R57ZHV85D4)  
calcium chloride (UNII: M4I0D6VV5M)  
hydrochloric acid (UNII: QTT17582CB)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
sodium borate (UNII: 91MBZ8H3QO)  
sodium chloride (UNII: 451W47IQ8X)  
sodium hydroxide (UNII: 55X04QC32I)  
sodium phosphate (UNII: SE337SVY37)  
trehalose (UNII: B8WCK70T7I)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58790-010-306 in 1 CARTON01/21/2021
15 in 1 POUCH
10.6 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/21/2021
Labeler - MEDTECH PRODUCTS INC (114707784)

Revised: 3/2022
Document Id: 735d60b9-9999-4e46-827c-abf2a2b70401
Set id: f1845041-9d8d-42a0-a2cb-68def7a5aac7
Version: 3
Effective Time: 20220322
 
MEDTECH PRODUCTS INC