Isopto Tears

Manufacturer
Alcon Laboratories, Inc. | Alcon Research Ltd
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:18:24

Label at a glance#

ProductIsopto Tears
Active ingredientHypromellose 2910 (4000 Mpa.s)
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hypromellose 2910 0.5%

OTC - PURPOSE SECTION

Lubricant

INDICATIONS & USAGE SECTION

Uses

  • For the temporary relief of burning and irritation due to dryness of the eye.
  • For use as a protectant against further irritation.

WARNINGS SECTION

For external use only
Do not use

  • if this solution changes color or becomes cloudy.
  • if you are sensitive to any ingredient in this product.

OTC - WHEN USING SECTION

When using this product

  • Remove contact lenses before using.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after each use.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you experience eye pain
  • you experience changes in vision
  • you experience continued redness or irritation
  • the 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.

DOSAGE & ADMINISTRATION SECTION

Directions

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

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • Store at room temperature.

INACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.01% as preservative, dibasic sodium phosphate, monobasic sodium phosphate, purified water, sodium chloride, sodium citrate.

OTC - QUESTIONS SECTION

In the U.S. call 1-800-757-9195

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alcon®

Isopto® Tears
LUBRICANT
Eye Drops
Hypromellose (Ophthalmic Solution)

For Relief of Dry Eyes

STERILE
15 mL (1/2 FL OZ)

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.

Alcon®

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA

World's largest manufacturer of ophthalmic preparations


©2000, 2010 Alcon, Inc.
Printed in USA


9001579-0410

Carton
Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0998-0408-15ML - Milliliter0998-0408d8e71ea3-1a7d-482a-aecb-a4afdc60e69812014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Hypromellose 2910 (4000 Mpa.s)ACTIVE INGREDIENTRN3152OP351
Hypromellose 2910 (4000 Mpa.s)ACTIVE MOIETYRN3152OP351
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W71
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULR1
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA741
Sodium Phosphate, MonobasicINACTIVE INGREDIENT3980JIH2SW1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0998-04080998-0408-15

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 181 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET / ORAL231 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSYSTEM / IONTOPHORESIS3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1800 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR360 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium Phosphate, MonobasicSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSYSTEM / IONTOPHORESIS14.2 mgExact identifier — unii candidate
9 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ORAL98 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium Phosphate, DibasicSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / INTRADERMAL0.2 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INFILTRATION648 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRATHECAL131 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XJELLY / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / PERIDURAL8.07 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ENDOTRACHEAL46.76 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRASYNOVIAL4 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / AURICULAR (OTIC)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Sodium Phosphate, DibasicSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / INTRAMUSCULAR40 mgExact identifier — unii candidate
14 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAMUSCULAR90 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVITREAL10 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, FILM COATED / ORAL100 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / RETROBULBAR648 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / NASAL330 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium Phosphate, DibasicSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / INTRAVENOUS200 mgExact identifier — unii candidate
14 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
134 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRALESIONAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, EMULSION / INTRAVENOUS0.62 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSPRAY, METERED / NASAL36 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / OPHTHALMIC3 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVENOUS90 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUPPOSITORY / RECTAL140 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium Phosphate, DibasicSODIUM PHOSPHATE, DIBASICGR686LBA74CONCENTRATE / ORAL17 mg/5mlExact identifier — unii candidate
14 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, EXTENDED RELEASE / ORAL335.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSYRUP / ORAL40 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SOFT TISSUE26 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium Phosphate, DibasicSODIUM PHOSPHATE, DIBASICGR686LBA74TABLET, EXTENDED RELEASE / ORAL143 mgExact identifier — unii candidate
14 equally ranked IID candidates
Sodium Phosphate, MonobasicSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS0.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER / TOPICALNAExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVASCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / NASAL40.46 mg/100mlExact identifier — unii candidate
24 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINHALANT / RESPIRATORY (INHALATION)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / RESPIRATORY (INHALATION)108 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / OPHTHALMIC13 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / PARENTERAL584 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium Phosphate, MonobasicSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION / INTRAMUSCULAR161 mgExact identifier — unii candidate
9 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / ENDOTRACHEAL7.6 mgExact identifier — unii candidate
134 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7CLOTH / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates

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
087ce08b-8271-4eda-9ac0-3554dbe54dd1f1753a5b-7ba8-103d-6fe4-d93a3fc5f8032023-12-14WarningsExact identifier
spl id: 087ce08b-8271-4eda-9ac0-3554dbe54dd1
spl set id: f1753a5b-7ba8-103d-6fe4-d93a3fc5f803

Reported adverse events (FAERS/openFDA)#

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