IFLYSMART GERM FREE- alcohol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Available from:

Calego International Inc.

Prescription type:

OTC DRUG

Therapeutic indications:

hand sanitizer to help reduce microbes on the skin

Authorization status:

OTC monograph not final

Summary of Product characteristics

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._
----------
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
F (43
C)
o
o
may discolor certain fabrics or surfaces
INACTIVE INGREDIENTS
carbomer, fragrance, glycerin, propylene glycol, silicone,
triethanolamine, water (aqua)
KIT LABEL
PACKAGE LABELING:
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)
PAC