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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. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. 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.
    Do not reuse. Once opened discard. Use individual vials within 90 days of opening foil pouch.
  • This product contains no preservatives. Any solution not used immediately after opening should he discarded. Re-use of this single-use product may lead to inflammation of the eye and/or discomfort, based on potential contamination during handling.

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.

Otc - 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.


Directions



  • To open, twist tab completely off.
  • Instill 1 or 2 drops of TheraTears® EXTRA® in the affected eye(s) as needed

Other Information



  • Use only if foil pouch is sealed and single-use container is intact.
  • Do not touch unit-dose tip to eye.

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.


Package Label.Principal Display Panel



Principal Display Panel Text for Container Label:

PRESERVATIVE FREE NDC 58790-010-30

thera

tears®

THERAPY FOR YOUR EYES®

EXTRA®

dry eye therapy

LUBRICANT

EYE DROPS

EXTRA MOISTURIZING

STERILE

5 Single-use

Vials 0.10 FL OZ (3.0 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


* Please review the disclaimer below.