GenTeal Tears

Manufacturer
Alcon Laboratories, Inc. | Excelvision
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:25

Label at a glance#

ProductGenTeal Tears Severe
Active ingredientHypromellose 2910 (4000 Mpa.S)
Label structure12 sections

Indications and uses

temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun as a protectant against further irritation or to relieve dryness of the eye

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 ingredientPurpose
Hypromellose 0.3%. Lubricant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun
  • as a protectant against further irritation or to relieve dryness of the eye

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if gel 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
  • replace cap after using

OTC - STOP USE SECTION

Stop use and ask a doctor if 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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • put 1 or 2 drops in the affected eye(s) as needed

Other information

SPL UNCLASSIFIED SECTION

  • store between 15º - 25ºC (59º - 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbopol 980, phosphonic acid, purified water, sodium hydroxide, sodium perborate, and sorbitol

Questions?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Severe DRY EYE SYMPTOM RELIEF
GEL

GenTeal
® Tears
LUBRICANT EYE GEL

GEL
Delivers Long-lasting relief of dry eye symptoms  

STERILE
10 g (0.34 FL OZ)

TAMPER EVIDENT:
For your protection, use only if pull tab is intact at time of purchase.

Distributed by: 
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA

Lot/Exp

Alcon

25368103

Severe Dry Eye Symptom Relief
Severe Dry Eye Symptom Relief

Severe DRY EYE SYMPTOM RELIEF

GenTeal® Tears

LUBRICANT EYE GEL

GEL

Delivers long-lasting relief of dry eye symptoms

STERILE 10g (0.34 FL OZ)

Active Ingredient: Hypromellose (0.3%) Uses: See carton for Uses.

Warnings: See carton for Warnings. When using this product do not touch tip of container to any surface. Replace cap after using. Directions: Put 1 or 2 drops in the affected eye(s) as needed. Other Information: Store between 15°-25°C (59°-77°F).

TAMPER EVIDENT: For your protection, use only if pull tab is intact at the time of purchase.

Distributed by: 
ALCON LABORATORIES, INC.
6201 South Freeway, Fort Worth, Texas 76134 USA


ALCON

16027802

Severe Dry Eye Symptom Relief
Severe Dry Eye Symptom Relief


DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
793204GenTeal Severe 0.3 % Ophthalmic GelPSN4
310932hypromellose 0.3 % Ophthalmic GelPSN4
793204hypromellose 0.003 MG/MG Ophthalmic Gel [GenTeal]SBD4
310932hypromellose 0.003 MG/MG Ophthalmic GelSCD4
793204GenTeal 0.003 MG/MG Ophthalmic GelSY4
793204GenTeal 0.3 % Ophthalmic GelSY4
310932hypromellose 0.3 % Ophthalmic GelSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-8064-01GenTeal Tears Severe10 g in 1 TUBEGEL104
0065-8064-01GenTeal Tears Severe1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-8064GENTEAL TEARS SEVERE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]4Current NDC, Legacy NDC, 2 package rows20231215_a57854fc-f3a2-4fbb-b718-cd06f87a721e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-8064-01GM - Gram0065-8064283b0849-8d39-4911-9da6-6a448e5f9f6112020-04-20

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
0065-80640065-8064-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML · Source PDF

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 SevereHYPROMELLOSEAlcon Laboratories, Inc.a57854fc-f3a2-4fbb-b718-cd06f87a721e2023-12-14WarningsExact identifier
ndc (package): 0065-8064-01
ndc (product): 0065-8064
ndc11 (package): 00065806401
spl id: 750c99c5-ade3-4759-870b-cb59248e9fa0
spl set id: a57854fc-f3a2-4fbb-b718-cd06f87a721e

Reported adverse events (FAERS/openFDA)#

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