Bion Tears Solution/ Drops
FDA Label NDC 0065-0419

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 0065-0419). 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, 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
Ingredients		Purpose
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

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 15o – 25o C (59o – 77o F).

Inactive Ingredients

Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium bicarbonate, sodium chloride, zinc chloride, hydrochloric acid and/or sodium hydroxide and/or 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®

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