FDA.reportPublic FDA data

GENTEAL TEARS

Manufacturer
A-S Medication Solutions
Effective date
2024-01-21
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:13:38

Label at a glance#

ProductGENTEAL TEARS
Active ingredientDEXTRAN 70, GLYCERIN, HYPROMELLOSES
Label structure13 sections

Indications and uses

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

Dosage and administration

put 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
Glycerin 0.2%Lubricant
Hypromellose 0.3%Lubricant

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of burning and irritation due to dryness of the eye
  • as a protectant against further irritation
  • temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

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

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience any of the following:

  • you feel eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • put 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

boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, POLYQUAD* (polyquaternium-1) 0.001% preservative, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-5050

NDC: 50090-5050-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

Questions?

OTC - QUESTIONS SECTION

In the U.S. call 1-800-757-9195
(Mon-Fri 9AM-5PM CST)
alcon.medinfo@alcon.com

Dextran 70, Glycerin, Hypromellose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
900138dextran 70 0.1 % / glycerin 0.2 % / hypromellose 0.3 % Ophthalmic SolutionPSN7
900138dextran 70 1 MG/ML / glycerin 2 MG/ML / hypromellose 3 MG/ML Ophthalmic SolutionSCD7
900138dextran 70 0.1 % / glycerin 0.2 % / hypromellose 0.3 % Ophthalmic SolutionSY7

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5050-02024-06-14C16284748780-1f386c649-a74c-0266-e053-dadaa90a7c1aGENTEAL TEARS
50090-5050-02023-01-30C16284748780-1f386c649-a74c-0266-e053-dadaa90a7c1aGENTEAL TEARS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5050-0GENTEAL TEARS15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS157
50090-5050-0GENTEAL TEARS1 in 1 CARTONSOLUTION/ DROPS17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5050GENTEAL TEARS (DEXTRAN 70, GLYCERIN, HYPROMELLOSE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20240615_a2b715e9-332d-4f0b-b8e5-ebc000681586.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5050-0ML - Milliliter50090-5050d9e68000-ed5a-4353-a5cb-d0faafd3438712024-07-12
0065-0426-22ML - Milliliter0065-0426d653da95-90e1-41cb-af5a-1ee71879f95d12013-02-13
0065-0426-36ML - Milliliter0065-042663cb5df3-87f3-4209-991d-ea9acf6327a412016-09-02
0065-0426-37ML - Milliliter0065-042611c2bcf5-cbd2-4b33-91bd-b81eaf93584312017-04-05

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-505050090-5050-0
0065-0426

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTRAN 707SA290YK68ACTIB
GLYCERINPDC6A3C0OXACTIB
HYPROMELLOSES3NXW29V3WOACTIB
Boric AcidR57ZHV85D4IACT
Calcium ChlorideM4I0D6VV5MIACT
GlycineTE7660XO1CIACT
Hydrochloric AcidQTT17582CBIACT
Sodium Hydroxide55X04QC32IIACT
Magnesium Chloride02F3473H9OIACT
Polidronium Chloride6716Z5YR3GIACT
Polysorbate 806OZP39ZG8HIACT
Potassium Chloride660YQ98I10IACT
Water059QF0KO0RIACT
Sodium Chloride451W47IQ8XIACT
Zinc Chloride86Q357L16BIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
ndc (package): 50090-5050-0
ndc (product): 50090-5050
ndc11 (package): 50090505000
spl id: 209fd8a1-720b-4308-abcd-29ca998d5f49
spl set id: a2b715e9-332d-4f0b-b8e5-ebc000681586
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
ndc (product): 0065-0426

Reported adverse events (FAERS/openFDA)#

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