Theratears Extra Md 58790-007

Theratears Extra Md 58790-007
SPL v5
SPL
SPL Set ID 77f504c1-b8e0-4371-ac3e-9d453d84714b
Route
OPHTHALMIC
Published
Effective Date 2024-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carboxymethylcellulose (2.5 mg)
Inactive Ingredients
Boric Acid Calcium Chloride Diethylenetriamine Pentamethylene Phosphonic Acid Potassium Chloride Sodium Bicarbonate Sodium Borate Sodium Chloride Magnesium Chloride Sodium Perborate Sodium Phosphate Trehalose Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-04-16

Description

Drug Facts

Purpose

Eye lubricant


Medication Information

Purpose

Eye lubricant

Description

Drug Facts

Uses
  • For use as a protectant against further irritation or to relieve dryness of the eye.

  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
Section 42229-5

Drug Facts

Warnings

For external use only

  • To avoid risk of contamination do not touch tip of opened container to any surface. Replace cap tightly after each use.
Directions

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

Do Not Use
  • if solution changes color or becomes cloudy.
Active Ingredient

Sodium carboxymethylcellulose 0.25%

Other Information
  • Do not use if neck ring is broken or missing.

  • Discard 45 days after opening.
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

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.

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)

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


Structured Label Content

Uses
  • For use as a protectant against further irritation or to relieve dryness of the eye.

  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
Section 42229-5 (42229-5)

Drug Facts

Purpose

Eye lubricant

Warnings

For external use only

  • To avoid risk of contamination do not touch tip of opened container to any surface. Replace cap tightly after each use.
Directions

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

Do Not Use (Do not use)
  • if solution changes color or becomes cloudy.
Active Ingredient (Active ingredient)

Sodium carboxymethylcellulose 0.25%

Other Information (Other information)
  • Do not use if neck ring is broken or missing.

  • Discard 45 days after opening.
Inactive Ingredients (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? (Questions or comments?)

1-800-579-8327

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

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)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)