FDA.reportPublic FDA data

GenTeal Tears (Mild)

Manufacturer
Alcon Laboratories, Inc. | Alcon Research LLC
Effective date
2019-12-11
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 23:11:16

Label at a glance#

ProductGenTeal Tears (Mild)
Active ingredientDextran 70, Hypromellose 2910 (4000 Mpa.s)
Label structure12 sections

Indications and uses

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

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
Hypromellose 2910 0.3%Lubricant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if 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
  • 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

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

POLYQUAD* (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium borate and 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

NDC 0065-0418-81

Mild DRY EYE SYMPTOM RELIEF

GenTeal* Tears

LUBRICANT EYE DROPS

LIQUID DROPS

Soothing Relief

PREVIOUSLY TEARS NATURALE* II

STERILE 15 mL (0.5 FL OZ)

Alcon®

TAMPER EVIDENT:
For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

GenTeal* Tears Mild Lubricant Eye Drops contains POLYQUAD* preservative, a safe and comfortable preservative, gentle enough for even sensitive eyes.

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

Country of Origin: USA

© 2015, 2016 Novartis

*trademark of Novartis

ACTUAL SIZE

9013370-0716

LOT:

EXP.:

Carton
Carton

NDC 0065-0418-81

Mild DRY EYE SYMPTOM RELIEF

GenTeal* Tears

LUBRICANT EYE DROPS

LIQUID DROPS

Soothing Relief

STERILE 15 mL (0.5 FL OZ)

STERILE – FOR TOPICAL EYE USE ONLY

TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase. Store at room temperature.

Alcon®

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

© 2015, 2016 Novartis

*trademark of Novartis

LOT/EXP.:

H14443-0716

Label
Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0418-15ML - Milliliter0065-04185e2d0109-1906-4ae8-9008-90a56815b58e12013-02-13
0065-0418-80ML - Milliliter0065-0418de7b45b3-f9fe-497a-947f-1c5e603d6c4a12017-06-15
0065-0418-81ML - Milliliter0065-041884b50e46-5682-497b-94a3-ecbdf083177c12016-05-16

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0065-04180065-0418-81, 0065-0418-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dextran 707SA290YK68ACTIB
Hypromellose 2910 (4000 Mpa.s)RN3152OP35ACTIB
Polidronium Chloride6716Z5YR3GIACT
Potassium Chloride660YQ98I10IACT
Water059QF0KO0RIACT
Sodium Borate91MBZ8H3QOIACT
Sodium Chloride451W47IQ8XIACT
Hydrochloric AcidQTT17582CBIACT
Sodium Hydroxide55X04QC32IIACT

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
462c5403-3746-421b-bbfc-d067a5780de6a1c43ff3-c16a-c58b-d61a-2e3c2abfd4962021-05-28WarningsExact identifier
spl set id: a1c43ff3-c16a-c58b-d61a-2e3c2abfd496

Reported adverse events (FAERS/openFDA)#

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