IFLY SMART ANTISEPTIC HAND- benzalkonium chloride swab

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Calego International Inc.

Podání:

TOPICAL

Druh předpisu:

OTC DRUG

Terapeutické indikace:

- for handwashing to decrease bacteria on the skin.

Stav Autorizace:

OTC monograph not final

Charakteristika produktu

IFLY SMART ANTISEPTIC HAND- BENZALKONIUM CHLORIDE SWAB
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 ANTISEPTIC HAND WIPES
_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
PACKAGE LABELING:
IFLY SMART ANTISEPTIC HAND
benzalkonium chloride swab
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7248 7-0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Calego International Inc.
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 1-0 8
8 in 1 BAG
10 /0 1/20 18
1
2.6 76 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System
(syringe, patch, etc.)
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 rt333A
10 /0 1/20 18
LABELER -
Calego International Inc. (081320445)
Revised: 8/2018