IFLY SMART- benzalkonium chloride kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

Calego International Inc

Prescription type:

OTC DRUG

Therapeutic indications:

- for handwashing to decrease bacteria on the skin

Authorization status:

OTC monograph not final

Summary of Product characteristics

IFLY SMART- BENZALKONIUM CHLORIDE
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 KIT
_DRUG FACTS_
_ACTIVE INGREDIENT_
Benzalkonium Chloride 0.13%
_PURPOSE_
Antiseptic
_USE_
for handwashing to decrease bacteria on the skin
_WARNINGS_
FOR EXTERNAL USE ONLY.
DO NOT USE
in the eyes
STOP USE AND ASK A DOCTOR IF
irritation and redness develop
condition persists for more than 72 hours
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away
_DIRECTIONS_
wet hands thoroughly with product and allow to dry without wiping
_INACTIVE INGREDIENTS_
Aloe Barbadensis Leaf Juice, Glycerin, Polysorbate 20, water
_QUESTIONS OR COMMENTS?_
To report a serious adverse event, contact 1-800-334-4577
PACKAGE LABELING:
PACKAGE LABELING:72487-002-07
PACKAGE LABELING:72487-003-08
IFLY SMART
benzalkonium chloride kit
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7248 7-0 0 2
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:7248 7-0 0 2-0 7
1 in 1 KIT
0 9 /15/20 19
QUANTITY OF PARTS
PART #
PACKAGE QUANTITY
TOTAL PRODUCT QUANTITY
PA RT 1
1 PATCH
2.6 76 g
PART 1 OF 1
Calego International Inc
IFLY SMART ANTISEPTIC HAND
benzalkonium chloride swab
PRODUCT INFORMATION
ITE M CODE (SOURCE )
NDC:7248 7-0 0 3
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6 JUD5X6 Y)
BENZALKONIUM
CHLORIDE
0 .13 g
in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
GLYCERIN (UNII: PDC6 A3C0 OX)
PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:7248 7-
0 0 3-0 8
8 in 1 BAG
1
2.6