FDA.reportPublic FDA data

FLORIL TEARS

Manufacturer
VITALINE S.A.C.
Effective date
2010-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:23:11

Label at a glance#

ProductFLORIL TEARS
Active ingredientPOLYVINYL ALCOHOL, POLYETHYLENE GLYCOL 400
Label structure10 sections

Indications and uses

temporary relief of eye dryness and redness due to insufficient production of tears. prevents further irritation.

Dosage and administration

Put 1 to 2 drops in the affected eyes up to times daily.

Storage and handling

Enter section text here

Label contents#

Full prescribing information#

Floril TEARS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton of Floril TearCarton of Floril Tear

OTC - ACTIVE INGREDIENT SECTION

Active ingredients     Purpose

Polyvinyl Alcohol  1,4%   Lubricant

Polyethylene Glycol 400 0,2% Lubricant

When using this product

OTC - WHEN USING SECTION

  • do not touch the tip of the container to any surface to avoid contamination
  • replace cap after each use
  • remove contact lenses before using

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • You feel eye pain
  • changes in vision occur
  • condition worsens or lasts more than 72 hours

Keep our 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium chloride, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, polysorbate 80, sodium chloride, purified water.

WARNINGS

WARNINGS SECTION

For external use only.

Do not use if the solution changes color or become cloudy.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Put 1 to 2 drops in the affected eyes up to times daily.

Other information

STORAGE AND HANDLING SECTION

Enter section text here

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of eye dryness and redness due to insufficient production of tears.
  • prevents further irritation.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039907Floril TEARS 0.2 % / 1.4 % Ophthalmic SolutionPSN2
1039905polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % Ophthalmic SolutionPSN2
1039907polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML Ophthalmic Solution [Floril Tears]SBD2
1039905polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML Ophthalmic SolutionSCD2
1039907Floril Tears (polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % ) Ophthalmic SolutionSY2
1039907Floril Tears (polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML) Ophthalmic SolutionSY2
1039905polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % Ophthalmic SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16995-002-012019-10-21C16284748780-1956f9ecf-dbde-621f-e053-dbdaa90a74ad22125054-98e6-47de-a56f-91ca54c318c4
16995-002-022019-10-21C16284748780-1956f9ecf-dbde-621f-e053-dbdaa90a74ad22125054-98e6-47de-a56f-91ca54c318c4
16995-002-032019-10-21C16284748780-1956f9ecf-dbde-621f-e053-dbdaa90a74ad22125054-98e6-47de-a56f-91ca54c318c4
16995-002-042019-10-21C16284748780-1956f9ecf-dbde-621f-e053-dbdaa90a74ad22125054-98e6-47de-a56f-91ca54c318c4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16995-002-01FLORIL TEARS3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS32
16995-002-02FLORIL TEARS10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS102
16995-002-03FLORIL TEARS15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
16995-002-04FLORIL TEARS30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16995-002FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.]2Legacy NDC, 4 package rows20100108_22125054-98e6-47de-a56f-91ca54c318c4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQ2
POLYVINYL ALCOHOLACTIVE INGREDIENT532B59J9902
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQ2
POLYVINYL ALCOHOLACTIVE MOIETY532B59J9902
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16995-00216995-002-01, 16995-002-02, 16995-002-03, 16995-002-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYVINYL ALCOHOL532B59J990ACTIB
POLYETHYLENE GLYCOL 400B697894SGQACTIB
WATER059QF0KO0RIACT

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
6becdef5-06d3-4a24-b46b-c8bb682a133922125054-98e6-47de-a56f-91ca54c318c42010-01-07WarningsExact identifier
spl id: 6becdef5-06d3-4a24-b46b-c8bb682a1339
spl set id: 22125054-98e6-47de-a56f-91ca54c318c4

Reported adverse events (FAERS/openFDA)#

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