IFLYSMART GERM FREE- alcohol 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]

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Use

hand sanitizer to help reduce microbes on the skin

Warnings

Flammable. Keep away from fire or flame

For external use only

When using this product,

do not use in or near the eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor

if irritation and redness develops and persists for more than 72 hours and continues

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 below 110 oF (43 oC)
• may discolor certain fabrics or surfaces

Inactive ingredients

carbomer, fragrance, glycerin, propylene glycol, silicone, triethanolamine, water (aqua)

Kit Label

Package Labeling:

INGREDIENTS AND APPEARANCE

IFLYSMART GERM FREE 
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72487-007

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72487-007-00	1 in 1 KIT	05/01/2020

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

Part 1 of 1

ANTIMICROBIAL HAND 
alcohol gel

Product Information
Item Code (Source)	NDC: 72487-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72487-008-02	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

Labeler - Calego International Inc. (081320445)