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

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

Kit

Package Labeling:

Bottle

IFLYSMART GERM FREE 
alcohol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72487-007
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72487-007-001 in 1 KIT05/01/202009/28/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 60 mL
Part 1 of 1
ANTIMICROBIAL HAND 
alcohol gel
Product Information
Item Code (Source)NDC:72487-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72487-008-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/202009/28/2022
Labeler - Calego International Inc. (081320445)

Revised: 9/2022
 
Calego International Inc.