IFLY SMART- benzalkonium chloride kit

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Calego International Inc
Prescription type:
OTC DRUG
Therapeutic indications:
- for handwashing to decrease bacteria on the skin
Authorization status:
OTC monograph not final
Authorization number:
72487-002-07, 72487-003-08

IFLY SMART- 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.

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iFly Smart 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

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

IFLY SMART

benzalkonium chloride kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7248 7-0 0 2

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7248 7-0 0 2-0 7

1 in 1 KIT

0 9 /15/20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 PATCH

2.6 76 g

Part 1 of 1

Calego International Inc

IFLY SMART ANTISEPTIC HAND

benzalkonium chloride swab

Product Information

Ite m Code (Source )

NDC:7248 7-0 0 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .13 g

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:7248 7-

0 0 3-0 8

8 in 1 BAG

1

2.6 76 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System

(syringe, patch, etc.)

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

10 /0 1/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 9 /15/20 19

Labeler -

Calego International Inc (081320445)

Revised: 9/2020

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