drug facts

drug facts
SPL v11
SPL
SPL Set ID e48d82f0-2f18-e514-4caa-e397d6713b99
Route
ophthalmic
Published
Effective Date 2023-05-18
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
calcium chloride magnesium chloride potassium chloride water sodium bicarbonate sodium chloride zinc chloride hydrochloric acid sodium hydroxide carbon dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 1992-10-19 Until 2025-12-31

Description

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


Medication Information

Warnings

For external use only

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

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

Store at room temperature.

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.

Description

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

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.

U.S. Patent no. 5,403,598



© 2003, 2005, 2006, 2009, 2021 Alcon, Inc.



Manufactured for:



Alcon



Alcon Laboratories, Inc.

Fort Worth, TX 76134-0109

Made in France



419199



Lot:

Exp.:







Questions?

In the U.S. call 1-800-757-9195 

www.tearsnaturale.com

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
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

Structured Label Content

Warnings

For external use only

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

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

Store at room temperature.

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 (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.

U.S. Patent no. 5,403,598



© 2003, 2005, 2006, 2009, 2021 Alcon, Inc.



Manufactured for:



Alcon



Alcon Laboratories, Inc.

Fort Worth, TX 76134-0109

Made in France



419199



Lot:

Exp.:







Questions?

In the U.S. call 1-800-757-9195 

www.tearsnaturale.com

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
Do Not Use (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 (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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