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  5. Label Information: Theratears Extra

FDA Label for Theratears Extra

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Theratears Extra Product Label

The following document was submitted to the FDA by the labeler of this product Medtech Products Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Sodium carboxymethylcellulose 0.25%


Purpose



Eye lubricant


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.

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 right away.


Directions



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


Other Information



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

Inactive Ingredients



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


Questions Or Comments?



1-800-579-8327


Package Label.Principal Display Panel



Principal Display Panel Text for Container Label:

NDC 58790-007-15

thera

tears®

THERAPY FOR YOUR EYES®

EXTRA

dry eye therapy

LUBRICANT

EYE DROPS

STERILE

0.5 FL OZ (15mL)

Principal Display Panel Text for Carton Label:

new!

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 (15mL)


* Please review the disclaimer below.