ANTIBACTERIAL- benzalkonium chloride 0.13% liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Benzalkonium chloride 0.13%.................Anitbacterial Hand soap

Available from:

TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI

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- BENZALKONIUM CHLORIDE 0.13% LIQUID
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI
_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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LUXURY HYGIENE ANTIBACTERIAL LIQUID HAND SOAP - MOISTURIZERS
ACTIVE INGREDIENTS
Benzalkonium chloride 0.13%.................Anitbacterial Hand soap
PURPOS E
Antibacterial
US E
for handwashing to decrease bacteria on the skin
WARNINGS
For external use only: hands only
WHEN USING THIS PRODUCT
avoid contact with 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 toroughly
INACTIVE INGREDIENTSC
water, sodium laureth sulfate , cocamidopropyl betaine, sodium
chloride, glycerin,
fragrance, polyquatemium-10 , PEG-8 , cidric acid, tetrasodium EDTA,
cocamidopropyl pg-dimonium
chrolide,
methylchloroisothiazolinone , methlisothiazolinone, blue 1, red 33
ADVERSE REACTIONS
TSM BRANDS LLC
540 Equinox Ln Manlapan, NJ 07726
Made in TURKEY.
PRINCIPAL DISPLAY PANEL
ANTIBACTERIAL
benzalkonium chloride 0.13% liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:76 772-0 0 6
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 g
in 1 mL
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )
CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)
PO LYQ UATERNIUM-10 ( 10 0 0 MPA.S AT 2 %) (UNII: GMR4PEN8 PK)
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
METHYL