Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 538c2a89-efb5-4132-b678-5a78f23cb713
Route
OPHTHALMIC
Published
Effective Date 2023-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextran 70 (1 mg) Hypromellose 2910 (4000 Mpa.s) (3 mg)
Inactive Ingredients
Sodium Chloride Potassium Chloride Magnesium Chloride Zinc Chloride Calcium Chloride Sodium Bicarbonate Water Carbon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-01

Description

Active Ingredients Purpose Dextran 70 0.1% Lubricant Hypromellose 2910 0.3% Lubricant


Medication Information

Description

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.

Section 50565-1

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

Section 55105-1
Active Ingredients Purpose
Dextran 70 0.1% Lubricant
Hypromellose 2910 0.3% Lubricant
Warnings

For external use only

Directions
  • Instill 1 or 2 drops in the affected eye(s) as needed.
Do Not Use
  • if this solution changes color or becomes cloudy.
  • if you are sensitive to any ingredient in this product.
Questions?

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

[email protected]

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

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

Structured Label Content

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

Section 50565-1 (50565-1)

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

Section 55105-1 (55105-1)
Active Ingredients Purpose
Dextran 70 0.1% Lubricant
Hypromellose 2910 0.3% Lubricant
Warnings

For external use only

Directions
  • Instill 1 or 2 drops in the affected eye(s) as needed.
Do Not Use (Do not use)
  • if this solution changes color or becomes cloudy.
  • if you are sensitive to any ingredient in this product.
Questions?

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

[email protected]

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 (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

When Using 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 (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

Advanced Ingredient Data


Raw Label Data

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