iFLYSmart Germ Free

Manufacturer
Calego International Inc.
Effective date
2021-11-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:20:31

Label at a glance#

ProductiFLYSmart Germ Free
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

put enough gel in your palm to cover hands and rub hands together rapidly until dry children under 6 years of age should be supervised when using this product

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

hand sanitizer to help reduce microbes on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame

For external use only

When using this product,

OTC - WHEN USING SECTION

do not use in or near the eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation and redness develops and persists for more than 72 hours and continues

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

  • put enough gel in your palm to cover hands and rub hands together rapidly until dry
  • children under 6 years of age should be supervised when using this product

Other information

SPL UNCLASSIFIED SECTION

  • store below 110 oF (43 oC)
  • may discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, fragrance, glycerin, propylene glycol, silicone, triethanolamine, water (aqua)

Kit Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KitKit

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72487-007-002021-12-28C16284748780-1c7ccaba7-1bbd-fd44-e053-dadaa90aa01biFLYSmart Germ-Free Kit
72487-007-002021-07-23C16284748780-1c7ccaba7-1bbd-fd44-e053-dadaa90aa01biFLYSmart Germ-Free Kit

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
72487-00772487-007-00
72487-00872487-008-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
e9d2b486-dcf2-b809-e053-2995a90aead0a599b870-9291-542e-e053-2995a90af7c22022-09-29WarningsExact identifier
spl set id: a599b870-9291-542e-e053-2995a90af7c2

Reported adverse events (FAERS/openFDA)#

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