FDA.reportPublic FDA data

iFly Smart

Manufacturer
Calego International Inc
Effective date
2020-09-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:14:45

Label at a glance#

ProductiFly Smart
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • for handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only.

Do not use 

OTC - DO NOT USE SECTION

in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition 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

wet hands thoroughly with product and allow to dry without wiping

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Glycerin, Polysorbate 20, water

Questions or comments?

OTC - QUESTIONS SECTION

To report a serious adverse event, contact 1-800-334-4577

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts PanelDrug Facts PanelKit LabelKit LabelBag LabelBag Label

Package Labeling:72487-002-07

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New LabelNew Label

Package Labeling:72487-003-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New Label2New Label2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72487-00272487-002-07
72487-00372487-003-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
e9d2ec8d-5576-d3a2-e053-2a95a90ad3b62306c19e-52ec-4fac-b478-4d99228349b52022-09-29WarningsExact identifier
spl set id: 2306c19e-52ec-4fac-b478-4d99228349b5

Reported adverse events (FAERS/openFDA)#

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