iFLYSmart Germ Free by Calego International Inc iFLYSmart Germ-Free Kit

iFLYSmart Germ Free by

Drug Labeling and Warnings

iFLYSmart Germ Free by is a Otc medication manufactured, distributed, or labeled by Calego International Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IFLYSMART GERM FREE- alcohol 
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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iFLYSmart Germ-Free Kit

Drug Facts

Active ingredient

Alcohol 75% v/v

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on skin.

Warnings

For external use only. Flammable.

Keep away from heat or flame.

Do not use

• on children less than 24 months of age
• on open skin wounds

When using this product

keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor.

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Put enough gel in your palm to cover hands and rub hands together rapidly until dry.
• Children under 6 years of age should be supervised when using this product

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 35C(95F)

Inactive ingredients

Aqua, Carbomer, Triethanolamine

Questions or comments?

To report a serious adverse event, contact 1-800-334-4577

Package Labeling:Kit

Package Labeling:60ml

IFLYSMART GERM FREE 
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72487-011

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72487-011-00	1 in 1 KIT	05/01/2020	09/28/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	60 mL

Part 1 of 1

ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Item Code (Source)	NDC: 72487-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72487-010-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020	09/28/2022

Labeler - Calego International Inc (081320445)

Revised: 9/2022

Document Id: e9d36c08-84ab-6300-e053-2a95a90ac60f

34390-5

Set id: 77780559-3b62-479e-9550-a37b8bda5088

Version: 3

Effective Time: 20220929