OPTISOURCE ANTIBACTERIAL FOAM HAND- benzalkonium chloride soap

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
04-12-2019

Aktiv ingrediens:

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

Tilgjengelig fra:

Charlotte Products Ltd.

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

Antimicrobial - For hand washing to decrease bacteria on the skin - Recommended for repeated use

Autorisasjon status:

OTC monograph not final

Preparatomtale

                                OPTISOURCE ANTIBACTERIAL FOAM HAND- BENZALKONIUM CHLORIDE SOAP
CHARLOTTE PRODUCTS LTD.
_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._
----------
ACTIVE INGREDIENT
Benzalkonium Chloride 0.13%
PURPOS E
Antimicrobial
US ES
For hand washing to decrease bacteria on the skin
Recommended for repeated use
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING
this product avoid contact with eyes. In case of eye contact, flush
eyes with water.
STOP USING AND ASK DOCTOR IF
irritation or redness develops, or if 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
Pump a small amount of foam into palm of hand
Rub thoroughly over all surfaces of both hands for 15 seconds
Rinse with potable water
INACTIVE INGREDIENTS Water/Agua/Eau, Coco-glucoside, Laurtrimonium
Chloride,
Cocamidopropylamine Oxide, Citric acid
OPTISOURCE ANTIBACTERIAL FOAM HAND
benzalkonium chloride soap
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 46 46 -0 0 1
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)
ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)
CO CAMIDO PRO PYLAMINE O XIDE (UNII: M4SL8 2J7HK)
LAURTRIMO NIUM CHLO RIDE (UNII: A8 1MSI0 FIC)
CO CO GLUCO SIDE (UNII: ICS79 0 225B)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:6 46 46 -0 0 1-
0 2
4 in 1 CASE
12/22/20 15
1
1250 mL in 1 BOTTLE, DISPENSING; Type 0 : No t a Co mbinatio n
Pro duc t
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 
                                
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