IFLY SMART- benzalkonium chloride 
Calego International Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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iFly Smart Kit

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

  • for handwashing to decrease bacteria on the skin

Warnings

For external use only.

Do not use 

in the eyes

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

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

Directions

wet hands thoroughly with product and allow to dry without wiping

Inactive ingredients

Aloe Barbadensis Leaf Juice, Glycerin, Polysorbate 20, water

Questions or comments?

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

Package Labeling:

Drug Facts PanelKit LabelBag Label

Package Labeling:72487-002-07

New Label

Package Labeling:72487-003-08

New Label2

IFLY SMART 
benzalkonium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72487-002
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72487-002-071 in 1 KIT09/15/201909/28/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PATCH 2.676 g
Part 1 of 1
IFLY SMART ANTISEPTIC HAND 
benzalkonium chloride swab
Product Information
Item Code (Source)NDC:72487-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72487-003-088 in 1 BAG
12.676 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/15/201909/28/2022
Labeler - Calego International Inc (081320445)

Revised: 9/2022
 
Calego International Inc