IFLY SMART ANTISEPTIC HAND- benzalkonium chloride swab
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 Antiseptic Hand Wipes

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:

Label

New Labeling:

New Label2

IFLY SMART ANTISEPTIC HAND
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72487-003
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/01/2018

Labeler - Calego International Inc. (081320445)