Bion Tears Solution/ Drops
FDA Label NDC 0065-9305

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alcon Laboratories, Inc. for the product Bion Tears (NDC 0065-9305). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if you experience, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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

* Please review the disclaimer below.