SIERRA SOFT NON-ALCOHOL FOAM HAND SANITIZER- benzalkonium chloride solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

CWGC LA Inc.

INN (International ime):

BENZALKONIUM CHLORIDE

Sastav:

BENZALKONIUM CHLORIDE 0.13 g in 100 mL

Administracija rute:

TOPICAL

Tip recepta:

OTC DRUG

Terapijske indikacije:

- For hand washing to reduce bacteria on the skin. Recommended for repeat use. Stop use and ask doctor if irritation or redness develops and persists.

Status autorizacije:

OTC monograph not final

Svojstava lijeka

SIERRA SOFT NON-ALCOHOL FOAM HAND SANITIZER- BENZALKONIUM
CHLORIDE SOLUTION
CWGC LA 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._
----------
CWGC (AS PLD) - SIERRA SOFT NON-ALCOHOL FOAM HAND SANITIZER
(70415-106)
ACTIVE INGREDIENT
BENZALKONIUM CHLORIDE 0.13%
PURPOSE
Antibacterial
USES
For hand washing to reduce bacteria on the skin. Recommended for
repeat use.
_WARNINGS_
For external use only.
Avoid contact with eyes - in case of contact, flush eyes with water.
Keep out of reach of children. If swallowed, get immediate medical
attention.
Stop use and ask doctor if irritation or redness develops and
persists.
_DIRECTIONS_
Apply foam sanitizer to hands. Rub over surfaces of both hands for 15
seconds. No
rinsing required.
INACTIVE INGREDIENTS
Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine
Oxide, Citric
Acid, Fragrance.
SIERRA SOFT NON-ALCOHOL FOAM HAND SANITIZER
benzalkonium chloride solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70415-106
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
0.13 g
in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
COCO GLUCOSIDE (UNII: ICS790225B)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
CWGC LA Inc.
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70415-
106-11
1000 mL in 1 BOTTLE; Type 0: Not a Combination
Product
05/04/2016
2
NDC:70415-
106-21
18925 mL in 1 PAIL; Type 0: Not a Combination
Product
10/04/2017
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part333E