KAY- benzalkonium chloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Kay Chemical Company

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic handwash - For handwashing to decrease bacteria on the skin

Authorization status:

OTC monograph not final

Summary of Product characteristics

KAY- BENZALKONIUM CHLORIDE SOLUTION
KAY CHEMICAL COMPANY
_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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Benzalkonium chloride 0.1%
PURPOSE
Antiseptic handwash
USES
For handwashing to decrease bacteria on the skin
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
In eyes
WHEN USING THIS PRODUCT
if in eyes, rinse promptly and thoroughly with water
discontinue use if irritation and redness develop
STOP USE AND ASK A DOCTOR IF
skin irritation and redness occurs 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
wash hands to remove soil
dispense palmful
spread to cover hands, rub in well
air dry, do not rinse or towel dry
OTHER INFORMATION
for additional information, see Safety Data Sheet (SDS)
MEDICAL EMERGENCY: [phone] or call collect 0 [phone]
INACTIVE INGREDIENTS water (aqua), isopropyl alcohol, propylene
glycol, CI 16035
(FD&C Red 40), CI 42090 (FD&C Blue 1)
QUESTIONS? Call 1-800-529-5458
PRINCIPAL DISPLAY PANEL AND REPRESENTATIVE LABEL
NDC 63146-109-10
KAY
Foaming Hand Sanitizer
KEEP OUT OF REACH OF CHILDREN - FOR INSTITUTIONAL USE ONLY
Benzalkonium chloride 0.1%
Net contents: 42 US fl oz (1250 ml)
Distributed by:
Kay Chemical Company • 8300 Capital Drive
Greensboro, NC 27409-9790 USA
Customer Service: [phone]
©2018 Kay Chemical Company
All rights reserved
757547-02 • KUSA 757547/8002/0618
KAY
benzalkonium chloride solution
PRODUCT INFORMATION
Kay Chemical Company
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63146-109
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 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0