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  5. Label Information: Isopto Tears

FDA Label for Isopto Tears

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT SECTION
    2. OTC - PURPOSE SECTION
    3. INDICATIONS & USAGE SECTION
    4. WARNINGS SECTION
    5. OTC - WHEN USING SECTION
    6. OTC - STOP USE SECTION
    7. OTC - KEEP OUT OF REACH OF CHILDREN SECTION
    8. DOSAGE & ADMINISTRATION SECTION
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENT SECTION
    11. OTC - QUESTIONS SECTION
    12. PRINCIPAL DISPLAY PANEL

Isopto Tears Product Label

The following document was submitted to the FDA by the labeler of this product Alcon Laboratories, 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.

Otc - Active Ingredient Section



Hypromellose 2910 0.5%


Otc - Purpose Section



Lubricant


Indications & Usage Section



Uses

  • For the temporary relief of burning and irritation due to dryness of the eye.
  • For use as a protectant against further irritation.

Warnings Section



For external use only
Do not use

  • if this solution changes color or becomes cloudy.
  • if you are sensitive to any ingredient in this product.

Otc - When Using Section



When using this product

  • Remove contact lenses before using.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after each use.

Otc - Stop Use Section



Stop use and ask a doctor if

  • you experience eye pain
  • you experience changes in vision
  • you experience continued redness or irritation
  • the condition worsens or persists for more than 72 hours

Otc - Keep Out Of Reach Of Children Section



Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.


Dosage & Administration Section



Directions

  • instill 1 or 2 drops in the affected eye(s) as needed.

Other Information



  • Store at room temperature.

Inactive Ingredient Section



Benzalkonium chloride 0.01% as preservative, dibasic sodium phosphate, monobasic sodium phosphate, purified water, sodium chloride, sodium citrate.


Otc - Questions Section



In the U.S. call 1-800-757-9195


Principal Display Panel



Alcon®

Isopto® Tears
LUBRICANT
Eye Drops
Hypromellose (Ophthalmic Solution)

For Relief of Dry Eyes

STERILE
15 mL (1/2 FL OZ)


* Please review the disclaimer below.