FDA.reportPublic FDA data

iFly smart Antiseptic Hand

Manufacturer
Calego International Inc.
Effective date
2020-09-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:29:50

Label at a glance#

ProductiFly smart Antiseptic Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

New Labeling: 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New Label2New Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN3
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD3
1038558benzalkonium chloride 0.13 % Topical ClothSY3
1038558benzalkonium chloride 0.13 % Topical SwabSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY3
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72487-003-082023-01-30C16284748780-1f386c649-b2b7-0266-e053-dadaa90a7c1aiFly smart Antiseptic Hand Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72487-003-08iFly smart Antiseptic Hand2.676 g in 1 PATCHSWAB2.6763
72487-003-08iFly smart Antiseptic Hand8 in 1 BAGSWAB83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72487-003IFLY SMART ANTISEPTIC HAND (BENZALKONIUM CHLORIDE) SWAB [CALEGO INTERNATIONAL INC.]3Legacy NDC, 2 package rows20200922_90cbdf96-4f02-5701-e053-2995a90a6373.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
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
af6ce079-748b-c8a6-e053-2a95a90a2ede90cbdf96-4f02-5701-e053-2995a90a63732020-09-16WarningsExact identifier
spl id: af6ce079-748b-c8a6-e053-2a95a90a2ede
spl set id: 90cbdf96-4f02-5701-e053-2995a90a6373

Reported adverse events (FAERS/openFDA)#

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