iFly smart Antiseptic Hand Wipes

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]

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.

----------

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

IFLY SMART ANTISEPTIC HAND 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72487-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72487-001-088 in 1 BAG10/01/201810/01/2018
12.676 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/201810/01/2018
Labeler - Calego International Inc. (081320445)

Revised: 1/2020
Document Id: 9d3464ae-4f41-102b-e053-2995a90af3de
Set id: 81b2e8a9-c556-4182-84b7-6acd734e9235
Version: 3
Effective Time: 20200128
 
Calego International Inc.