iFly smart TRAVEL by Calego International Inc iFly smart TRAVEL Kit

iFly smart TRAVEL by

Drug Labeling and Warnings

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

Drug Details [pdf]

IFLY SMART TRAVEL- 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.

----------

iFly smart TRAVEL 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

Water, Glycerin, Aloe Barbadensis Leaf Juice, Polysorbate 20

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

iFly smart TRAVEL Kit (72487-000-00)

iFly smart Antiseptic Hand Wipes 8 Count (72487-001-08)

IFLY SMART TRAVEL 
benzalkonium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72487-000

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72487-000-00	1 in 1 KIT	10/01/2018	10/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	8 PATCH	21.408 g

Part 1 of 1

IFLY SMART ANTISEPTIC HAND 
benzalkonium chloride swab

Product Information
Item Code (Source)	NDC: 72487-001
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		8 in 1 PACKAGE
1	NDC: 72487-001-08	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	part333A	10/01/2018	10/01/2018

Labeler - Calego International Inc (081320445)

Revised: 12/2019

Document Id: 9af1e1ca-d2e8-f400-e053-2a95a90a24e6

34390-5

Set id: 9368ec77-1cf1-4245-a581-f1aaaa03e667

Version: 3

Effective Time: 20191230

 

Calego International Inc