FDA.reportPublic FDA data

Tears Naturale Free

Manufacturer
Alcon Laboratories, Inc. | Kaysersberg Pharmaceuticals | Catalent Pharma Solutions, LLC
Effective date
2020-03-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:38:02

Label at a glance#

ProductTears Naturale Free
Active ingredientHypromellose 2910 (4000 Mpa.s), Dextran 70
Label structure12 sections

Indications and uses

For the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun.

Dosage and administration

Instill one or two 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

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

  • Instill one or two drops in the affected eye(s) as needed.

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature.

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 or Comments? Call Us.

OTC - QUESTIONS SECTION

In the U.S. call 1 (800) 757-9195 or visit www.tearsnaturale.com 






TEARS Naturale FREE® LUBRICANT EYE DROPS PERFORMANCE GUARANTEE (see side panel)


PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mild/Moderate Dry Eye

Preservative Free

TEARS Naturale FREE®

LUBRICANT EYE DROPS

60 Single-Use Vials
0.9 mL (0.03 FL OZ Each

STERILE

Alcon®

Convenience
 Tears Naturale Free® Lubricant Eye Drops provide lasting relief for mild to moderate dry eye with the convenience of a vial.

Guaranteed to provide relief.
TEARS NATURALE FREE® Lubricant Eye Drops is guaranteed to provide temporary relief of dry eye symptoms. Prove it to yourself at no risk. If TEARS NATURALE FREE® Lubricant Eye Drops does not provide you with the relief you expect, you may return the unused portion with evidence of price paid to
Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, Texas 76134, for an immediate and full refund.

TAMPER EVIDENT:
Do not use if vial is damaged or opened.
© 2002, 2003, 2006, 2008, 2012 Novartis

Manufactured for:
Alcon®
ALCON LABORATORIES, INC.
FORT WORTH, TX 76134 USA
MADE IN FRANCE

427294

9008140-0512
 
Preservative Free
TEARS Naturale FREE®
(Dextran 70 0.1% and Hypromellose 2910 0.3%)
LUBRICANT EYE DROP

DIRECTIONS:
Make sure container is intact before use.
To open, completely TWIST off tab.
Do NOT pull off.

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

Throw away container. Do not reuse.

See more information at www.tearsnaturale.com

Carton
Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0416-22EA - Each0065-04164b3e4a8d-6849-46e8-8b75-a4e308c2fb8212013-02-13
0065-0416-25EA - Each0065-0416b720f143-b6ac-4199-a272-9bb6936ec80a12013-02-13
0065-0416-36EA - Each0065-0416a66eb4af-b12c-4dff-bea7-dcdc4d4d2bd312016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Dextran 70ACTIVE INGREDIENT7SA290YK681
Hypromellose 2910 (4000 Mpa.s)ACTIVE INGREDIENTRN3152OP351
Dextran 70ACTIVE MOIETY7SA290YK681
Hypromellose 2910 (4000 Mpa.s)ACTIVE MOIETYRN3152OP351
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB1
Potassium ChlorideINACTIVE INGREDIENT660YQ98I101
Sodium BorateINACTIVE INGREDIENT91MBZ8H3QO1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
WaterINACTIVE INGREDIENT059QF0KO0R1

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
0065-04160065-0416-22, 0065-0416-25, 0065-0416-36

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

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 8 · 480 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRASYNOVIAL4 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBLIQUID / NASALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ITABLET, FILM COATED / ORAL8 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IENEMA / RECTAL0.44 %v/vExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRAVENOUS720 mgExact identifier — unii candidate
148 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XDROPS / OPHTHALMIC0.08 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER / TOPICALNAExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL1.35 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVENOUS456 mgExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / PERIDURALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRATUMORADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION, CONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVENOUS90 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL11 mgExact identifier — unii candidate
134 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRA-ARTERIAL840 mgExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVENOUS2.78 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium BorateSODIUM BORATE91MBZ8H3QOSOLUTION / OPHTHALMIC2 mgExact identifier — unii candidate
6 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii candidate
134 equally ranked IID candidates
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10SUSPENSION / ORALNAExact identifier — unii candidate
18 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / ORAL1126 mgExact identifier — unii candidate
134 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTERSTITIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IEMULSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INFILTRATION648 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / EPIDURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-ARTERIAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / URETERALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRATHECAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBEMULSION / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSYRUP / ORAL40 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVENOUS28773 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSYSTEM / IONTOPHORESIS3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / TOPICAL0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSPRAY / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRAVITREALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10INJECTION, SOLUTION / INTRAVENOUS330 mgExact identifier — unii candidate
18 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR24 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / ENDOTRACHEAL7.6 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / IONTOPHORESIS0.6 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, FILM COATED / ORAL100 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSYSTEM / TOPICAL3.1 mgExact identifier — unii candidate
134 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
e3453d29-253a-4681-a47c-f2c90bb6c8a2854f7b68-0d8b-04e3-dc1a-d53d08fa748c2020-03-20WarningsExact identifier
spl id: e3453d29-253a-4681-a47c-f2c90bb6c8a2
spl set id: 854f7b68-0d8b-04e3-dc1a-d53d08fa748c

Reported adverse events (FAERS/openFDA)#

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