FDA.reportPublic FDA data

Biolle Tears

Manufacturer
SAGE Ethnographic Research, dba Biollé
Effective date
2016-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:33

Label at a glance#

ProductBiolle Tears
Active ingredientCarboxymethylcellulose Sodium, Unspecified Form
Label structure11 sections

Indications and uses

- For temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. - May be used as a protectant against further irritation.

Dosage and administration

To open, twist and pull tab to remove. Drop 1 to 2 drops in the affected eye as needed and discard the container.

Storage and handling

- Use before expiration date marked on container. - Store at 59-86 F (15-30C). - Retain this carton for future reference.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Carboxymethylcellulose sodium 0.5%

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Boric Acid, calcium chloride; magnesium chloride, potassium chloride; purified water, sodium borate; and sodium chloride. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

Uses

INDICATIONS & USAGE SECTION

  • For temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
  • May be used as a protectant against further irritation.

WARNINGS SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists 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.

Other Information

STORAGE AND HANDLING SECTION

  • Use before expiration date marked on container.
  • Store at 59-86 F (15-30C).
  • Retain this carton for future reference.

Warnings

WARNINGS SECTION

  • For external use only.
  • To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • If solution changes color or becomes cloudy, do not use.

Directions

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

To open, twist and pull tab to remove.

DirectionsDirections

Drop 1 to 2 drops in the affected eye as needed and discard the container.

SPL UNCLASSIFIED SECTION

Distributed by:
Biollé a Division of SAGE
Ethnographic Research.
PO Box 1386
New York, NY 10185

PRINCIPAL DISPLAY PANEL - 0.6 mL Vial Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Preservative-Free

Biollé
Tears®

Rejuvenation in every drop

Moderate dry eye relief
32 Single-use containers
0.02 fl oz (0.6mL) each sterile

PRINCIPAL DISPLAY PANEL - 0.6 mL Vial Carton
PRINCIPAL DISPLAY PANEL - 0.6 mL Vial Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionPSN1
1188426carboxymethylcellulose sodium 5 MG/ML Ophthalmic SolutionSCD1
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionSY1
1188426carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
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
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69994-001-022020-01-31C16284748780-19d75b9d0-a4a1-f424-e053-dadaa90a57ceBiollé Tears ®
69994-001-042020-01-31C16284748780-19d75b9d0-a4a1-f424-e053-dadaa90a57ceBiollé Tears ®
69994-001-102020-01-31C16284748780-19d75b9d0-a4a1-f424-e053-dadaa90a57ceBiollé Tears ®
69994-001-322020-01-31C16284748780-19d75b9d0-a4a1-f424-e053-dadaa90a57ceBiollé Tears ®
69994-001-522020-01-31C16284748780-19d75b9d0-a4a1-f424-e053-dadaa90a57ceBiollé Tears ®
69994-001-722020-01-31C16284748780-19d75b9d0-a4a1-f424-e053-dadaa90a57ceBiollé Tears ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69994-001-02Biolle Tears2 in 1 CARTONSOLUTION/ DROPS21
69994-001-02Biolle Tears4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS41
69994-001-04Biolle Tears4 in 1 CARTONSOLUTION/ DROPS41
69994-001-04Biolle Tears4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS41
69994-001-10Biolle Tears102 in 1 CARTONSOLUTION/ DROPS1021
69994-001-10Biolle Tears4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS41
69994-001-32Biolle Tears32 in 1 CARTONSOLUTION/ DROPS321
69994-001-32Biolle Tears4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS41
69994-001-52Biolle Tears52 in 1 CARTONSOLUTION/ DROPS521
69994-001-52Biolle Tears4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS41
69994-001-72Biolle Tears72 in 1 CARTONSOLUTION/ DROPS721
69994-001-72Biolle Tears4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69994-001BIOLLE TEARS (CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM) SOLUTION/ DROPS [SAGE ETHNOGRAPHIC RESEARCH, DBA BIOLLÉ]1Legacy NDC, 12 package rows20160328_f3d6856a-d447-4745-89e7-86cac83ce579.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69994-001-32EA - Each69994-00177b82ace-9c6f-4b2d-b9e4-34c0769501d912024-04-05

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69994-00169994-001-32, 69994-001-72, 69994-001-10, 69994-001-02, 69994-001-52, 69994-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Carboxymethylcellulose Sodium, Unspecified FormK679OBS311ACTIB
Calcium ChlorideM4I0D6VV5MIACT
Magnesium Chloride02F3473H9OIACT
Potassium Chloride660YQ98I10IACT
Water059QF0KO0RIACT
Sodium Chloride451W47IQ8XIACT
Sodium LactateTU7HW0W0QTIACT
Hydrochloric AcidQTT17582CBIACT
Sodium Hydroxide55X04QC32IIACT

Source Document#

Source XML

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
96c60497-1326-4cf4-a63f-60b28164948df3d6856a-d447-4745-89e7-86cac83ce5792016-03-25WarningsExact identifier
spl id: 96c60497-1326-4cf4-a63f-60b28164948d
spl set id: f3d6856a-d447-4745-89e7-86cac83ce579

Reported adverse events (FAERS/openFDA)#

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