FDA.reportPublic FDA data

BION TEARS

Manufacturer
Alcon Laboratories, Inc. | Kaysersberg Pharmaceuticals
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:04:31

Label at a glance#

ProductBION TEARS
Active ingredientDextran 70, Hypromellose 2910 (4000 Mpa.s)
Label structure12 sections

Indications and uses

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

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) as needed.

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Dextran 70 0.1% Lubricant
Hypromellose 2910 0.3% Lubricant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if this solution changes color or becomes cloudy.
  • if you are sensitive to any ingredient in this product.

When using 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.

Stop use and ask a doctor if you experience

OTC - STOP USE SECTION

  • 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

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature.

Inactive Ingredients

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.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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.:



carton
carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1088217BION TEARS 0.1 % / 0.3 % Ophthalmic SolutionPSN11
309714dextran 70 0.1 % / hypromellose 0.3 % Ophthalmic SolutionPSN11
1088217dextran 70 1 MG/ML / hypromellose 3 MG/ML Ophthalmic Solution [Bion Tears]SBD11
309714dextran 70 1 MG/ML / hypromellose 3 MG/ML Ophthalmic SolutionSCD11
1088217Bion Tears (dextran 70 0.1 % / hypromellose 0.3 % ) Ophthalmic SolutionSY11
309714dextran 70 0.1 % / hypromellose 0.3 % Ophthalmic DropsSY11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTRAN 70 Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-0419-18BION TEARS28 in 1 CARTONSOLUTION/ DROPS2811
0065-0419-18BION TEARS0.4 mL in 1 VIALSOLUTION/ DROPS0.411
0065-0419-28BION TEARS0.4 mL in 1 VIALSOLUTION/ DROPS0.411
0065-0419-28BION TEARS28 in 1 CARTONSOLUTION/ DROPS2811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0419BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]11Current NDC, Legacy NDC, 4 package rows20231215_e48d82f0-2f18-e514-4caa-e397d6713b99.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0419-18EA - Each0065-041957facf56-1432-4487-bb2f-0ac24729ebda12016-07-19
0065-0419-28EA - Each0065-0419647b105c-1411-4cdf-9d10-e29d8e12941b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Dextran 70ACTIVE INGREDIENT7SA290YK681
Hypromellose 2910 (4000 Mpa.s)ACTIVE INGREDIENTRN3152OP351
Dextran 70ACTIVE MOIETY7SA290YK681
HypromellosesACTIVE MOIETY3NXW29V3WO1
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5M1
Carbon DioxideINACTIVE INGREDIENT142M471B3J1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB1
Magnesium ChlorideINACTIVE INGREDIENT02F3473H9O1
Potassium ChlorideINACTIVE INGREDIENT660YQ98I101
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QO1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
WaterINACTIVE INGREDIENT059QF0KO0R1
Zinc ChlorideINACTIVE INGREDIENT86Q357L16B1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0065-04190065-0419-28, 0065-0419-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dextran 707SA290YK68ACTIB
Hypromellose 2910 (4000 Mpa.s)RN3152OP35ACTIB
Calcium ChlorideM4I0D6VV5MIACT
Magnesium Chloride02F3473H9OIACT
Potassium Chloride660YQ98I10IACT
Water059QF0KO0RIACT
Sodium Bicarbonate8MDF5V39QOIACT
Sodium Chloride451W47IQ8XIACT
Zinc Chloride86Q357L16BIACT
Hydrochloric AcidQTT17582CBIACT
Sodium Hydroxide55X04QC32IIACT
Carbon Dioxide142M471B3JIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 126 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET / ORAL1300 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOGRANULE, EFFERVESCENT / ORAL267 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING / ORAL107 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, SOLUTION / INTRAVENOUS52 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, EFFERVESCENT / ORAL57600 mgExact identifier — unii candidate
102 equally ranked IID candidates
Magnesium ChlorideMAGNESIUM CHLORIDE02F3473H9OSOLUTION/ DROPS / OPHTHALMIC0.03 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET / BUCCAL42 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
102 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Zinc ChlorideZINC CHLORIDE86Q357L16BSOLUTION/ DROPS / OPHTHALMICNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOLOZENGE / ORAL100 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING / ORAL107 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, EXTENDED RELEASE / ORAL81 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / ORAL360 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOGRANULE, EFFERVESCENT / ORAL267 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
102 equally ranked IID candidates
Calcium ChlorideCALCIUM CHLORIDEM4I0D6VV5MSOLUTION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / ORALADJ PHExact identifier — unii candidate
102 equally ranked IID candidates
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
102 equally ranked IID candidates
Carbon DioxideCARBON DIOXIDE142M471B3JINJECTION / INTRAVENOUSADJ PHExact identifier — unii candidate
3 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS160 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAVITREAL0.18 %w/vExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / RESPIRATORY (INHALATION)2 %w/wExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS3059 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAMUSCULAR175 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOPOWDER, FOR SOLUTION / ORAL1250 mg/100mlExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS160 mgExact identifier — unii candidate
102 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOCAPSULE, DELAYED RELEASE PELLETS / ORAL4 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS3219 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, FILM COATED / ORAL86 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, SOLUTION / INTRAVENOUS52 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / INTRATHECAL0.05 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING / ORAL107 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, COATED / ORAL10.6 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOLOZENGE / ORAL100 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, EXTENDED RELEASE / ORAL81 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAVENOUS812 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOGRANULE, EFFERVESCENT / ORAL267 mgExact identifier — unii candidate
102 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS3059 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAMUSCULAR175 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOPOWDER, FOR SOLUTION / ORAL1250 mg/100mlExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / ORALADJ PHExact identifier — unii candidate
102 equally ranked IID candidates
Carbon DioxideCARBON DIOXIDE142M471B3JINJECTION / INTRAVENOUSADJ PHExact identifier — unii candidate
3 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii candidate
102 equally ranked IID candidates
Sodium BicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS160 mgExact identifier — unii candidate
102 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BION TEARSDEXTRAN, HYPROMELLOSEAlcon Laboratories, Inc.e48d82f0-2f18-e514-4caa-e397d6713b992023-12-14WarningsExact identifier
ndc (package): 0065-0419-28
ndc (package): 0065-0419-18
ndc (product): 0065-0419
ndc11 (package): 00065041918
ndc11 (package): 00065041928
spl id: 34aa9128-4bc4-45a6-aeae-a8c1f7699183
spl set id: e48d82f0-2f18-e514-4caa-e397d6713b99

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.