IFLYSMART FLY HAPPY AND CLEAN KIT- benzalkonium chloride kit

iFLYSmart Fly Happy And Clean Kit by

Drug Labeling and Warnings

iFLYSmart Fly Happy And Clean Kit 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

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

Package Labeling: 72487-003-08

Package Labeling: 72487-004-00

INGREDIENTS AND APPEARANCE

IFLYSMART FLY HAPPY AND CLEAN KIT 
benzalkonium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72487-004

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72487-004-00	1 in 1 KIT	05/10/2020

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	05/10/2020

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)