Label: BION TEARS- dextran, hypromellose solution/ drops
- NDC Code(s): 0065-0419-18, 0065-0419-28
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated November 7, 2019
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
- Do not use
- When using this product
- Stop use and ask a doctor if you experience
- KEEP OUT OF REACH OF CHILDREN
- Other Information
- Inactive Ingredients
In the U.S. call 1-800-757-9195
PRINCIPAL DISPLAY PANEL
Severe Dry Eye
LUBRICANT EYE DROPS
28 Single-Use Vials
0.4 ml (0.015 FL OZ) Each
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.
Alcon Laboratories, Inc.
Fort Worth, TX 76134-0109
Made in France
INGREDIENTS AND APPEARANCE
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)