BENZALKONIUM CHLORIDE- benzalkonium chloride 0.13% soap

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

BENZALKONIUM CHLORIDE- BENZALKONIUM CHLORIDE 0.13% SOAP
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 ANTIBACTERIAL HAND SOAP 858.000/858AA
ACTIVE INGREDIENT
Benzalkonium chloride 0.13%
PURPOSE
Antibacterial
USE
for handwashing to decrease bacteria on the skin
WARNINGS
FOR EXTERNAL USE ONLY: HAND ONLY
WHEN USING THIS PRODUCT
avoid contact with eyes. If contact occurs, rinse eyes thoroughly 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, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine
oxide, sodium
chloride, myristamidopropylamine oxide, glycerin, fragrance, limonene,
disteareth-75
IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA,
benzophenone-4, sodium
benzoate, orange 4, red 33
*Washing hands helps wash away bacteria and germs
Distributed by:
Vi-Jon, LLC, St. Louis, MO 63114
PRINCIPAL DISPLAY PANEL
germ-X
SINCE 1997
ANTIBACTERIAL
HAND SOAP
CITRUS PEEL SCENT
WASHES AWAY GERMS*
pH Balanced, Dermatologist Tested
FORMULA MADE IN USA EMPLOYEE-OWNED
16 FL OZ (473 mL)
BENZALKONIUM CHLORIDE
benzalkonium chloride 0.13% soap
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:11344-858
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
1.3 g
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
SODIUM CHLORIDE (UNII: 451W4