IFLY SMART ANTIBACTERIAL HAND SANITIZER- alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Calego International Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
For handwashing to decrease bacteria on skin.
Authorization status:
OTC monograph not final
Authorization number:
72487-012-00

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IFLY SMART ANTIBACTERIAL HAND SANITIZER- alcohol gel

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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iFLY Smart Antibacterial Hand Sanitizer

Drug Facts

Active ingredient

Ethyl 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 child less than 24 months of age

on open skin wounds

When using this product

keep out of eyee, 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 40C (104F)

Inactive ingredients

Water, Glycerin, Squalane,Panthenol, Inulin, Sodium Hyaluronate, Fructose, Tocopheryl Acetate,

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

Package Labeling:

IFLY SMART ANTIBACTERIAL HAND SANITIZER

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7248 7-0 12

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

0 .75 L in 1 L

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

SQ UALANE (UNII: GW8 9 575KF9 )

PANTHENO L (UNII: WV9 CM0 O6 7Z)

INULIN (UNII: JOS53KRJ0 1)

Calego International Inc.

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

FRUCTO SE (UNII: 6 YSS42VSEV)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7248 7-0 12-0 0

2.1 L in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/15/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

11/15/20 20

Labeler -

Calego International Inc. (081320445)

Revised: 12/2020

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