FDA.reportPublic FDA data

GenTeal Tears Moderate Preservative Free

Manufacturer
Alcon Laboratories, Inc. | Kaysersberg Pharmaceuticals
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:04:19

Label at a glance#

ProductGenTeal Tears Moderate Preservative Free
Active ingredientHypromellose 2910 (4000 Mpa.s), Dextran 70
Label structure12 sections

Indications and uses

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.

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

  • 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

  • to avoid contamination, do not touch tip of container to any surface
  • do not reuse
  • once opened, discard

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience any of the following:

  • 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

OTHER SAFETY INFORMATION

  • store are room temperature 15o – 25o C (59o – 77o F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

potassium chloride, purified water, sodium borate, sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?               

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRESERVATIVE FREE

Moderate DRY EYE SYMPTOM RELIEF

GenTeal® Tears

LUBRICANT EYE DROPS

LIQUID DROPS

Fast, Soothing Relief
Preservative Free Formula

Previously TEARS NATURALE® FREE LUBRICANT EYE DROPS

STERILE  36 Single-Use Vials 0.9 mL (0.03 FL OZ) Each

Alcon

GenTeal® Tears Lubricant Eye Drops
Preservative Free provide lasting relief
for moderate dry eye with the
convenience of a vial.

TAMPER EVIDENTY:
Do not use if vial is damaged or opened.

Distributed by:
Alcon Laboratories, Inc.,
6201 South Freeway
Fort Worth, Texas 76134

Country of Origin: France

435581

Carton Label
Carton Label
Carton Label
Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309714dextran 70 0.1 % / hypromellose 0.3 % Ophthalmic SolutionPSN8
309714dextran 70 1 MG/ML / hypromellose 3 MG/ML Ophthalmic SolutionSCD8
309714dextran 70 0.1 % / hypromellose 0.3 % Ophthalmic DropsSY8

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
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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
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-8063-01GenTeal Tears Moderate Preservative Free.9 mL in 1 VIAL, SINGLE-DOSESOLUTION/ DROPS.98
0065-8063-01GenTeal Tears Moderate Preservative Free36 in 1 CARTONSOLUTION/ DROPS368

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-8063GENTEAL TEARS MODERATE PRESERVATIVE FREE (DEXTRAN 70, HYPROMELLOSE 2910) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]8Current NDC, Legacy NDC, 2 package rows20231215_37686e54-e64d-47c8-b082-b944a23cf6f1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-8063-01EA - Each0065-8063f4819051-22bf-468b-b025-1f66c402169c12018-10-11

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
0065-80630065-8063-01

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
Dextran 707SA290YK68ACTIB
Potassium Chloride660YQ98I10IACT
Water059QF0KO0RIACT
Sodium Borate91MBZ8H3QOIACT
Hydrochloric AcidQTT17582CBIACT
Sodium Hydroxide55X04QC32IIACT
Sodium Chloride451W47IQ8XIACT

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
GenTeal Tears Moderate Preservative FreeDEXTRAN 70, HYPROMELLOSE 2910Alcon Laboratories, Inc.37686e54-e64d-47c8-b082-b944a23cf6f12023-12-14WarningsExact identifier
ndc (package): 0065-8063-01
ndc (product): 0065-8063
ndc11 (package): 00065806301
spl id: f7885429-659f-40b7-bbd7-d8680d1912f2
spl set id: 37686e54-e64d-47c8-b082-b944a23cf6f1

Reported adverse events (FAERS/openFDA)#

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