iFLYSmart Fly Happy And Clean Kit

Manufacturer
Calego International Inc
Effective date
2020-09-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:29:53

Label at a glance#

ProductiFLYSmart Fly Happy And Clean Kit
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 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

OTC - QUESTIONS SECTION

TO REPORT A SERIOUS ADVERSE EVENT, CONTACT 1-800-334-4577

Package Labeling: 72487-003-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DrugComponentDrugComponent

Package Labeling: 72487-004-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KitKit

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2
1038558benzalkonium chloride 0.13 % Topical ClothSY2
1038558benzalkonium chloride 0.13 % Topical SwabSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72487-004-002023-01-30C16284748780-1f386c64a-01bb-0266-e053-dadaa90a7c1aiFLYSmart Fly Happy & Clean Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72487-003-08iFLYSmart Fly Happy And Clean Kit2.676 g in 1 PATCHSWAB2.676 g0.13 g in 100g2
72487-003-08iFLYSmart Fly Happy And Clean Kit8 in 1 BAGSWAB0.13 g in 100g2
72487-004-00iFLYSmart Fly Happy And Clean Kit1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72487-003IFLYSMART FLY HAPPY AND CLEAN KIT (BENZALKONIUM CHLORIDE) KIT [CALEGO INTERNATIONAL INC]2Legacy NDC20200922_d02e7e72-2085-43a4-8a26-44b24b284a45.zip
72487-004IFLYSMART FLY HAPPY AND CLEAN KIT (BENZALKONIUM CHLORIDE) KIT [CALEGO INTERNATIONAL INC]2Legacy NDC, 3 package rows20200922_d02e7e72-2085-43a4-8a26-44b24b284a45.zip

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
72487-00472487-004-00
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.

Source Document#

Source XML · Source PDF

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
afd0381b-4675-a220-e053-2995a90a879fd02e7e72-2085-43a4-8a26-44b24b284a452020-09-21WarningsExact identifier
spl id: afd0381b-4675-a220-e053-2995a90a879f
spl set id: d02e7e72-2085-43a4-8a26-44b24b284a45

Reported adverse events (FAERS/openFDA)#

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