ANTIBACTERIAL HAND WASH- benzalkonium chloride 0.13% liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Vi-Jon, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antibacterial for handwashing to decrease bacteria on the skin - irritation or redness develops - condition persists for more than 72 hours

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANTIBACTERIAL HAND WASH- BENZALKONIUM CHLORIDE 0.13% LIQUID
VI-JON, 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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GERM-X 460.001 460AB
CLAIMS
germ-x
ANTIBACTERIAL
FOAMING
HAND WASH
ACTIVE INGREDIENT
Benzalkonium chloride 0.13%
PURPOSE
Antibacterial
USE
for handwashing to decrease bacteria on the skin
WARNINGS
For external use only: hands only
WHEN USING THIS PRODUCT
avoid contact with the eyes. If contact occurs, rinse eyes with water
STOP USE AND ASK A DOCTOR IF
irritation or redness develops
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
apply palmful to hands
scrub thoroughly
rinse thoroughly
INACTIVE INGREDIENTS
water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine
oxide,
myristamidopropylamine oxide, glycerin, fragrance, citric acid,
tetrasodium EDTA,
benzophenone-4, sodium benzoate, red 4, yellow 5
ADVERSE REACTIONS
DISTRIBUTED BY: VI-JON, LLC, ST. LOUIS, MO 63114
PRINCIPAL DISPLAY PANEL
HELPS KILL HARMFUL GERMS
germ-X
ANTIBACTERIAL
FOAMING
HAND SOAP
ANTIBACTERIAL FOAMING HAND SOAP
Gentle and Mild Formula
Quick Foaming
7.5 FL OZ (221mL)
ANTIBACTERIAL HAND WASH
benzalkonium chloride 0.13% liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:11344-460
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
1.313 mg
in 1 mL
INACTIVE INGREDIENTS
Vi-Jon, LLC
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE