085 Lubricating eye drops

Manufacturer
OTE North America | Ote Pharma Sol B.V.
Effective date
2025-02-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:56:01

Label at a glance#

ProductHydropure Lubricating Eye Drops
Active ingredientGLYCERIN
Label structure13 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Glycerin 0.25%

Purpose

OTC - PURPOSE SECTION

Eye Lubricant

INDICATIONS & USAGE SECTION

Uses

■ For the temporary relief of burning and irritation due to dryness of the eye ■ For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun ■ For use as a protectant against further irritation or to temporarily relieve dryness of the eye

WARNINGS SECTION

Warnings for External use only.

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

Do not use

OTC - DO NOT USE SECTION

Do not use ■ If solution changes color or becomes cloudy ■ If tamper evident ring is broken or missing.

When using this product

OTC - WHEN USING SECTION

When using this product ■ Do not touch tip of container to any surface to avoid contamination

■ Replace cap after use.

Stop use and ask a doctor if

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, discontinue use and consult a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

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

INACTIVE INGREDIENT SECTION

Inactive ingredients: borate, boric acid, sodium chloride, calcium chloride, l-carnitine, sodium hyaluronate

Other information

SPL UNCLASSIFIED SECTION

■ Store at 15 - 25 C (59-77 F).

Questions?

OTC - QUESTIONS SECTION

Questions?

Call + 1-800-203-9156

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310541glycerin 0.25 % Ophthalmic SolutionPSN3
310541glycerin 2.5 MG/ML Ophthalmic SolutionSCD3
310541glycerin 0.25 % Ophthalmic SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product 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
84227-851-10Hydropure Lubricating Eye Drops1 in 1 CARTONSOLUTION/ DROPS13
84227-851-10Hydropure Lubricating Eye Drops10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84227-851HYDROPURE LUBRICATING EYE DROPS (GLYCERIN) SOLUTION/ DROPS [OTE NORTH AMERICA]3Current NDC, 2 package rows20250227_17f5b6e5-dc14-45c7-e063-6294a90af43d.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84227-85184227-851-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
Hydropure Lubricating Eye DropsGLYCERINOTE North America17f5b6e5-dc14-45c7-e063-6294a90af43d2025-02-14WarningsExact identifier
ndc (package): 84227-851-10
ndc (product): 84227-851
ndc11 (package): 84227085110
spl id: 2b9a93b2-85df-df06-e063-6394a90a1a7f
spl set id: 17f5b6e5-dc14-45c7-e063-6294a90af43d

Reported adverse events (FAERS/openFDA)#

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