FDA.reportPublic FDA data

FLORIL TEARS

Manufacturer
VITALINE S.A.C.
Effective date
2010-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:24:55

Label at a glance#

ProductFLORIL TEARS
Active ingredientPOLYVINYL ALCOHOL
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#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients     Purpose

Polyvinyl Alcohol  1,4%   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, polyethylene glycol 300, 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Floril Tears BoxFloril Tears BoxEnter section text here

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039907Floril TEARS 0.2 % / 1.4 % Ophthalmic SolutionPSN1
1039905polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % Ophthalmic SolutionPSN1
1039907polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML Ophthalmic Solution [Floril Tears]SBD1
1039905polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML Ophthalmic SolutionSCD1
1039907Floril Tears (polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % ) Ophthalmic SolutionSY1
1039907Floril Tears (polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML) Ophthalmic SolutionSY1
1039905polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % Ophthalmic SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16995-004-012019-10-21C16284748780-1956f9ecf-c6a8-621f-e053-dbdaa90a74ad8101c006-0b47-4484-8760-a959764f555c
16995-004-022019-10-21C16284748780-1956f9ecf-c6a8-621f-e053-dbdaa90a74ad8101c006-0b47-4484-8760-a959764f555c
16995-004-032019-10-21C16284748780-1956f9ecf-c6a8-621f-e053-dbdaa90a74ad8101c006-0b47-4484-8760-a959764f555c
16995-004-042019-10-21C16284748780-1956f9ecf-c6a8-621f-e053-dbdaa90a74ad8101c006-0b47-4484-8760-a959764f555c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16995-004-01FLORIL TEARS3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS31
16995-004-02FLORIL TEARS10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS101
16995-004-03FLORIL TEARS15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS151
16995-004-04FLORIL TEARS30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16995-004FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.]1Legacy NDC, 4 package rows20100629_8101c006-0b47-4484-8760-a959764f555c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POLYVINYL ALCOHOLACTIVE INGREDIENT532B59J9901
POLYVINYL ALCOHOLACTIVE MOIETY532B59J9901
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQ1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
16995-00416995-004-01, 16995-004-02, 16995-004-03, 16995-004-04

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
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT

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 1 · 13 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQSOLUTION / INTRAVENOUS16920 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQOINTMENT / OPHTHALMICNAExact identifier — unii candidate
13 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQOINTMENT / TOPICAL1114 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQCREAM / TOPICAL20 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQINJECTION / INTRAVENOUS16950 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQINJECTION / INTRAMUSCULAR16950 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQSOLUTION / TOPICAL29.7 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS44.22 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQLIQUID / INTRAVENOUS5850 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQDROPS / AURICULAR (OTIC)97.43 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQSOLUTION / INTRAMUSCULAR16920 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQTABLET / ORAL1 mgExact identifier — unii candidate
13 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
94f2f212-eba2-47a6-96ac-9f9639e2a09d8101c006-0b47-4484-8760-a959764f555c2010-06-22WarningsExact identifier
spl id: 94f2f212-eba2-47a6-96ac-9f9639e2a09d
spl set id: 8101c006-0b47-4484-8760-a959764f555c

Reported adverse events (FAERS/openFDA)#

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