FDA.reportPublic FDA data

FLORIL REDNESS RELIEF

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 22:23:12

Label at a glance#

ProductFLORIL REDNESS RELIEF
Active ingredientNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 20
Label structure10 sections

Dosage and administration

Put 1 to 2 drops in the affected eye(s) up to 4 times daily.

Storage and handling

Store at room temperature 15° to 30° (59° to 86° F).

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box floril redness reliefBox floril redness relief

Actives ingredients Purpose

OTC - ACTIVE INGREDIENT SECTION

Naphazoline Hydrocloride 0,03% redness reliever
Polysorbate 20 0,24% Lubricant

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

WARNINGS

WARNINGS SECTION

For external use only

Ask a doctor before use if you have narrow angle glaucoma

Do not use if the solution changes color or becomes cloudy

OTC - WHEN USING SECTION

  • do not touch the tip of the container to any surface to avoid contamination
  • replace cap after each use
  • overuse may cause more eye redness
  • pupils may become enlarged temporarily
  • remove contact lenses before using

Stop use and ask doctor if

OTC - STOP USE SECTION

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away

Use

INDICATIONS & USAGE SECTION

Relieves redness of the eye due to minor eye irritations

Directions

DOSAGE & ADMINISTRATION SECTION

Put 1 to 2 drops in the affected eye(s) up to 4 times daily.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15° to 30° (59° to 86° F).

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16995-001-012019-10-21C16284748780-1956f9ecf-cf30-621f-e053-dbdaa90a74adbe1d52aa-2a40-42d6-8108-ab02bb37711b
16995-001-022019-10-21C16284748780-1956f9ecf-cf30-621f-e053-dbdaa90a74adbe1d52aa-2a40-42d6-8108-ab02bb37711b
16995-001-032019-10-21C16284748780-1956f9ecf-cf30-621f-e053-dbdaa90a74adbe1d52aa-2a40-42d6-8108-ab02bb37711b
16995-001-042019-10-21C16284748780-1956f9ecf-cf30-621f-e053-dbdaa90a74adbe1d52aa-2a40-42d6-8108-ab02bb37711b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16995-001-01FLORIL REDNESS RELIEF3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS32
16995-001-02FLORIL REDNESS RELIEF10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS102
16995-001-03FLORIL REDNESS RELIEF15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
16995-001-04FLORIL REDNESS RELIEF30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16995-001FLORIL REDNESS RELIEF (NAPHAZOLINE HYDROCHLORIDE ) SOLUTION/ DROPS [VITALINE S.A.C.]2Legacy NDC, 4 package rows20100108_be1d52aa-2a40-42d6-8108-ab02bb37711b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
NAPHAZOLINE HYDROCHLORIDEACTIVE INGREDIENTMZ1131787D2
POLYSORBATE 20ACTIVE INGREDIENT7T1F30V5YH2
NAPHAZOLINEACTIVE MOIETYH231GF11BV2
POLYSORBATE 20ACTIVE MOIETY7T1F30V5YH2
LIMEINACTIVE INGREDIENTC7X2M0VVNH2

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16995-00116995-001-01, 16995-001-02, 16995-001-03, 16995-001-04

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
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB
POLYSORBATE 207T1F30V5YHACTIB
LIMEC7X2M0VVNHIACT

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LIMELIME (CALCIUM OXIDE)C7X2M0VVNHCAPSULE / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
LIMELIME (CALCIUM OXIDE)C7X2M0VVNHSOLUTION, CONCENTRATE / ORAL0.1 ml/1mlExact identifier — unii candidate
2 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
e4ff216e-e4a8-4c7e-b752-ce1621eba1b5be1d52aa-2a40-42d6-8108-ab02bb37711b2010-01-07WarningsExact identifier
spl id: e4ff216e-e4a8-4c7e-b752-ce1621eba1b5
spl set id: be1d52aa-2a40-42d6-8108-ab02bb37711b

Reported adverse events (FAERS/openFDA)#

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