FDA Label for Bion Tears

View Indications, Usage & Precautions

Bion 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 - Purpose



Active IngredientsPurpose
Dextran 70 0.1% Lubricant
Hypromellose 2910 0.3% Lubricant

Uses



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


Warnings



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.

When Using This Product



  • To avoid contamination, do not touch tip of container to any surface.
  • Do not touch unit-dose tip to eye.
  • Do not reuse.
  • Once opened, discard.

Stop Use And Ask A Doctor If You Experience



  • eye pain
  • changes in vision
  • continued redness
  • irritation of the eye
  • symptoms worsening or persisting 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



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

Other Information



Store at room temperature.


Inactive Ingredients



Sodium chloride, potassium chloride, magnesium chloride hexahydrate, zinc chloride, calcium chloride dihydrate, sodium bicarbonate, purified water and carbon dioxide to adjust pH.


Questions?



In the U.S. call 1-800-757-9195 or email
[email protected]


Principal Display Panel



Severe Dry Eye

Preservative-Free

BION® TEARS

LUBRICANT EYE DROPS

28 Single-Use Vials

0.4 ml (0.015 FL OZ) Each

STERILE

Alcon

DIRECTIONS (HOW TO USE)

Make sure container is intact before use.
To open, COMPLETELY TWIST OFF TAB.
Do not pull off.

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

Throw away container.
Do not reuse.
Once opened, discard.
All four containers within a pouch must be used within four days of opening the pouch.

Tamper Evident: Containers are sealed in a protective foil pouch. Use only if foil pouch is undamaged at time of purchase.

BION® TEARS Lubricant Eye Drops is an advanced tear substitute especially formulated and packaged for persistent dry eye conditions requiring frequent therapy.

MONEY BACK GUARANTEED

To fully assess comfort, a 3 to 4-week trial of BION® TEARS is recommended when switching from another brand of lubricant eye drops. If, however, you are not satisfied with the comfort BION® TEARS provides, we ask that you send the unused portion of the product and the sales receipt, with a brief description of why you were dissatisfied, to QA/Consumer Affairs, Alcon Laboratories, Fort Worth, TX 76134-2099. You will receive a full refund within 6 to 8 weeks.

Manufactured for:
Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76134-0109
Made in France

438230


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