PREMIUM ANTIBACTERIAL HAND- benzalkonium chloride soap

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Produktets egenskaber Produktets egenskaber (SPC)
10-12-2020

Aktiv bestanddel:

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

Tilgængelig fra:

Insolcorp, LLC

Indgivelsesvej:

TOPICAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

Antibacterial For washing to decrease bacteria on the skin STOP USE AND ASK A DOCTOR IF irritation and redness develops

Autorisation status:

OTC monograph not final

Produktets egenskaber

                                PREMIUM ANTIBACTERIAL HAND- BENZALKONIUM CHLORIDE SOAP
INSOLCORP, LLC
_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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PREMIUM ANTIBACTERIAL HAND SOAP
ACTIVE INGREDIENT
Benzalkonium Chloride 0.13%
PURPOSE
Antibacterial
USE
For washing to decrease bacteria on the skin
WARNINGS
For external use only
WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. Incase of eye contact
flush
with water.
STOP USE AND ASK A DOCTOR IF irritation and redness develops
KEEP OUT OF THE REACH OF CHILDREN IF SWALLOWED, get medical help or
contact a
poision control
center right away.
DIRECTIONS
Pump into dry hands and forearms, lather for atleast 15 seconds, rinse
and dry.
INACTIVE INGREDIENTS
Water, Caprylyl / Capryl Glucosides, Laurtrimonium Chloride,
Cocamidoprpylamine Oxide, Citric
Acid, Fragrance
PRINCIPAL DISPLAY PANEL
PREMIUM ANTIBACTERIAL HAND SOAP
LEMON BLOSSOM
8 FL. OZ. (240 mL)
PREMIUM ANTIBACTERIAL HAND
benzalkonium chloride soap
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:748 11-0 0 2
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
1.3 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
DECYL GLUCO SIDE (UNII: Z17H9 7EA6 Y)
LAURTRIMO NIUM CHLO RIDE (UNII: A8 1MSI0 FIC)
CO CAMIDO PRO PYLAMINE O XIDE (UNII: M4SL8 2J7HK)
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:748 11-0 0 2-
0 1
240 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n
Pro duc t
12/10 /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 rt333A
12/10 /20 20
Insolcorp, LLC
LA
                                
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