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  5. Label Information: Theratears

FDA Label for Theratears

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH UNIT DOSE)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. OTC - QUESTIONS
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Theratears 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.

Other



Drug Facts


Active Ingredient (In Each Unit Dose)



sodium carboxymethylcellulose 1%


Purpose



Eye lubricant


Uses



  • As a lubricant to relieve dryness of the eye.
  • As a protectant against further irritation of the eye.
  • For temporary relief of burning, irritation, and discomfort including exposure to wind or sun.

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 be 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 immediately.


Directions



  • To open, twist tab completely off.
  • Instill 1 or 2 drops 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



Borate buffers, calcium chloride, magnesium chloride, potassium chloride, purified water, sodium bicarbonate, sodium chloride and sodium phosphate


Otc - Questions



Questions or comments?        1-800-579-8327


Package Label.Principal Display Panel



Principal Display Panel Text for Container Label:

PRESERVATIVE FREE

thera

tears®

THERAPY FOR YOUR EYES®

Liquid Gel

nighttime

dry eye therapy

LUBRICANT EYE GEL

SOOTHING

OVERNIGHT

RELIEF

STERILE

4 Single-Use

Vials 0.08 FL OZ (2.4mL) TOTAL

Principal Display Panel Text for Carton Label:

PRESERVATIVE

FREE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

Liquid Gel

nighttime

dry eye therapy

LUBRICANT EYE GEL

SOOTHING

OVERNIGHT

RELIEF

28 STERILE

Single-Use Vials* 0.57 FL OZ (16.8mL) TOTAL


* Please review the disclaimer below.