Package Insert and Label Information: BION TEARS
BION TEARS — dextran 70 and hypromellose 2910 (4000 mpa.s) solution/ drops
Alcon Laboratories, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
cartonOTC — ACTIVE INGREDIENT SECTION
Dextran 70 0.1%
Hypromellose 2910 0.3%
OTC — PURPOSE SECTION
Lubricant
INDICATIONS & USAGE SECTION
-
For use as a protectant against further irritation or to relieve dryness of the eye.
WARNINGS SECTION
For external use only
OTC — DO NOT USE SECTION
- if this solution changes color or becomes cloudy.
- if you are sensitive to any ingredient in this product.
OTC — WHEN USING SECTION
- 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.
OTC — 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 SECTION
If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
- Instill 1 or 2 drops in the affected eye(s) as needed.
OTHER INFORMATION
Store at room temperature.
INACTIVE INGREDIENT SECTION
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.
OTC — QUESTIONS SECTION
In the U.S. call 1-800-757-9195
www.tearsnaturale.com
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 Alcon, Inc.
Manufactured for:
Alcon®
Alcon Laboratories, Inc.
Fort Worth, TX 76134-2099
Made in France
9001814-0109
419197
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
STERILEAlcon®
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| Labeler — Alcon Laboratories, Inc. (008018525) |
| Registrant — Alcon Laboratories, Inc. (008018525) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Laboratories Alcon S.A. | 501958300 | MANUFACTURE | |
Revised: 01/2009 Alcon Laboratories, Inc.
