FDA.reportPublic FDA data

HylaTears

Manufacturer
Hyalogic LLC | Optikem International, Inc.
Effective date
2025-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:53:22

Label at a glance#

ProductHylaTears
Active ingredientHYPROMELLOSE 2910 (4000 MPA.S)
Label structure1 sections

Label contents#

Full prescribing information#

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

All the text in the principal panelAll the text in the principal panel

Directions

DOSAGE & ADMINISTRATION SECTION

Instill one or two drops in the affected eye(s) as needed.

Dosage and AdministrationDosage and Administration

OTC - PURPOSE SECTION

PurposePurpose

Purpose: Lubricant

Keep out of Reach

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of ReachKeep out of ReachKeep out of reach of children

WARNINGS SECTION

WarningsWarningsFor external use only.

If you are pregnant, nursing, trying to conceive, taking any medications, or have a medical condition, please consult your healthcare practitioner before using this product.

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.

Do not use if solution changes color or becomes cloudy.

If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive IngredientsInactive Ingredients:
Water, sodium chloride, sodium hyaluron-ate, potassium chloride, sodium phosphate dibasic, sodium phosphate monobasic, benzyl alcohol.

OTC - ACTIVE INGREDIENT SECTION

Hypromellose 0.3% Lubricant

List of active ingredientsList of active ingredients

Inidication and Use

INDICATIONS & USAGE SECTION

For the temporary relief of burning, irritaiton and discomofrt due to drynes of the eye or exposure to wind and sun,. May be uysed as a protectant against further irritation

Indication and UseIndication and Use

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct 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
72094-001-03HylaTears20 mL in 1 BOTTLE, DROPPERLIQUID202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72094-001HYLATEARS (EYE DROPS) LIQUID [HYALOGIC LLC]2Current NDC, Legacy NDC, 1 package rows20250123_2b5fc4c4-843c-8d3d-e063-6394a90a5a1b.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72094-00172094-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSE 2910 (4000 MPA.S)RN3152OP35ACTIB
POTASSIUM CHLORIDE660YQ98I10IACT
SODIUM PHOSPHATE DIBASIC DIHYDRATE94255I6E2TIACT
BENZYL ALCOHOLLKG8494WBHIACT
WATER059QF0KO0RIACT
SODIUM HYALURONATEYSE9PPT4THIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT

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
HylaTearsEYE DROPSHyalogic LLC2b5fc4c4-843c-8d3d-e063-6394a90a5a1b2025-01-10WarningsExact identifier
ndc (package): 72094-001-03
ndc (product): 72094-001
ndc11 (package): 72094000103
spl id: 2b5fc4c4-843d-8d3d-e063-6394a90a5a1b
spl set id: 2b5fc4c4-843c-8d3d-e063-6394a90a5a1b

Reported adverse events (FAERS/openFDA)#

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