IFLY SMART- benzalkonium chloride kit

iFly Smart by

Drug Labeling and Warnings

iFly Smart by is a Otc medication manufactured, distributed, or labeled by Calego International Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

Package Labeling:72487-002-07

Package Labeling:72487-003-08

INGREDIENTS AND APPEARANCE

IFLY SMART 
benzalkonium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72487-002

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72487-002-07	1 in 1 KIT	09/15/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72487-003-08	8 in 1 BAG
1		2.676 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/15/2019

Labeler - Calego International Inc (081320445)