AERO CARE HANDY QUAT ANTISEPTIC HANDWASH- benzalkonium chloride soap

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ABC Compounding Co., Inc.

INN (International Name):

BENZALKONIUM CHLORIDE

Composition:

BENZALKONIUM CHLORIDE 25.0 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic for hand-washing to decrease bacteria on the skin irritation and redness develop

Authorization status:

OTC monograph not final

Summary of Product characteristics

AERO CARE HANDY QUAT ANTISEPTIC HANDWASH- BENZALKONIUM CHLORIDE SOAP
ABC COMPOUNDING CO., 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._
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AERO CARE HANDY QUAT ANTISEPTIC HANDWASH 6265 DRUG FACTS AND LABEL
DRUG FACTS BOX OTC-ACTIVE INGREDIENT SECTION
Benzalkonium Chloride 2.5%
DRUG FACTS BOX OTC-PURPOSE SECTION
Antiseptic
DRUG FACTS BOX OTC-INDICATIONS & USAGE SECTION
for hand-washing to decrease bacteria on the skin
DRUG FACTS BOX OTC-WARNINGS SECTION
FOR EXTERNAL USE ONLY
DRUG FACTS BOX OTC-WHEN USING SECTION
do not get into eyes
if contact occurs, rinse eyes thoroughly with water
DRUG FACTS BOX OTC-STOP USE SECTION
irritation and redness develop
DRUG FACTS BOX OTC-KEEP OUT OF REACH OF CHILDREN SECTION
if swallowed, get medical help or contact a Poison Control Center
right away
DRUG FACTS BOX OTC-DOSAGE & ADMINISTRATION SECTION
wet hands and forearms
apply 5 milliliters (teaspoonful) or palmful to hands and forearms
scrub thoroughly for 1 minute and rinse
DRUG FACTS BOX OTC-INACTIVE INGREDIENTS SECTION
water, glycerin, isopropyl alcohol, disodium cocoamphodiproprionate,
hydroxyethylcellulose,
lauramine oxide,
PEG-75 lanolin, citric acid, FD and C red no.4
HANDY QUAT 6265 1 GALLON LABEL
Handy Quat 6265 1 Gallon Label
AERO CARE HANDY QUAT ANTISEPTIC HANDWASH
benzalkonium chloride soap
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 2257-26 5
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
25.0 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)
HYDRO XYETHYL CELLULO SE ( 150 0 MPA.S AT 1%) (UNII: L6 0 5B58 9 2V)
DISO DIUM CO CO AMPHO DIPRO PIO NATE (UNII: 6 K8 PRP39 7M)
LAURAMIN