BION TEARS- dextran, hypromellose solution/ drops

BION TEARS by

Drug Labeling and Warnings

BION TEARS by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Kaysersberg Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• 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

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

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.

Questions?

In the U.S. call 1-800-757-9195
www.tearsnaturale.com
MedInfo@AlconLabs.com

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 your 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 Alcon, Inc.

Manufactured for:

Alcon®

Alcon Laboratories, Inc.
Fort Worth, TX 76134-0109
Made in France
9001814-0109
41917

INGREDIENTS AND APPEARANCE

BION TEARS 
dextran, hypromellose solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-0419
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68)	Dextran 70	1 mg  in 1 mL
Hypromellose 2910 (4000 Mpa.s) (UNII: RN3152OP35) (Hypromellose 2910 (4000 Mpa.s) - UNII:RN3152OP35)	Hypromellose 2910 (4000 Mpa.s)	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Calcium Chloride (UNII: M4I0D6VV5M)
Magnesium Chloride (UNII: 02F3473H9O)
Potassium Chloride (UNII: 660YQ98I10)
Water (UNII: 059QF0KO0R)
Sodium Bicarbonate (UNII: 8MDF5V39QO)
Sodium Chloride (UNII: 451W47IQ8X)
Zinc Chloride (UNII: 86Q357L16B)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)
Carbon Dioxide (UNII: 142M471B3J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0419-28	28 in 1 CARTON	10/20/2000	12/21/2017
1		0.4 mL in 1 VIAL; Type 0: Not a Combination Product
2	NDC: 0065-0419-18	28 in 1 CARTON	10/20/2000
2		0.4 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	10/19/1992

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Kaysersberg Pharmaceuticals		267486052	manufacture(0065-0419)