SIERRA SOFT NON-ALCOHOL FOAM SANITIZER- benzalkonium chloride gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

CWGC LA Inc.

INN (International Name):

BENZALKONIUM CHLORIDE

Composition:

BENZALKONIUM CHLORIDE 0.1 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- For sanitizing to reduce bacteria on the skin.

Authorization status:

OTC monograph not final

Summary of Product characteristics

SIERRA SOFT NON-ALCOHOL FOAM SANITIZER- BENZALKONIUM CHLORIDE GEL
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
(70415-103)
ACTIVE INGREDIENT
BENZALKONIUM CHLORIDE 0.13%
PURPOSE
Antibacterial
USES
For sanitizing to reduce bacteria on the skin.
_WARNINGS_
FOR EXTERNAL USE ONLY
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control
Center right away.
_DIRECTIONS_
TO USE, SIMPLY PLACE CARTRIDGE INTO DISPENSER AND USE STRAIGHT; DO NOT
DILUTE. APPLY 1 PUMP OF SANITIZER ONTO HANDS AND RUB INTO SKIN. NO
RINSING
REQUIRED.
INACTIVE INGREDIENTS
Water, Propylene Glycol, Cocamidopropyl Betaine, Cocamine Oxide,
Disodium EDTA,
DMDM Hydantoin, Triethanolamine, Fragrance, FD&C Yellow No.5, FD&C
Blue No.1.
SIERRA SOFT NON-ALCOHOL FOAM SANITIZER
benzalkonium chloride gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70415-103
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
BENZ ALKONIUM
0.1 g
CWGC LA Inc.
UNII:7N6JUD5X6Y)
CHLORIDE
in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70415-
103-11
1000 mL in 1 BOTTLE; Type 0: Not a Combination
Product
05/04/2016
2
NDC:70415-
103-12
1250 mL in 1 BOTTLE; Type 0: Not a Combination
Product
05/04/2016
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part333E
05/04/2016
LABELER -
CWGC LA Inc. (034967904)
Revised: 9/2023