IFLY SMART ANTISEPTIC HAND- benzalkonium chloride swab

iFly smart Antiseptic Hand by

Drug Labeling and Warnings

iFly smart Antiseptic Hand 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

Package Labeling:

New Labeling: 

INGREDIENTS AND APPEARANCE

IFLY SMART ANTISEPTIC HAND 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	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	10/01/2018
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

Labeler - Calego International Inc. (081320445)