HAND SANITIZER- benzalkonium chloride gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by QuadSil Inc, Tri Pac. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS:

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Inactive Ingredients

Cyclopentasiloxane, Dimethacone, Crosspolymer, PPG-3, Benzyl Ether Ethylhexanoate, Octadecyldimethyl Trimethoxysilylpropyl Ammonium Chloride.

USES

For Hand Sanitizing.

DIRECTIONS

Prime pump, use one pump to cover both hands.

WARNINGS

The Human Corona Virus is not COVID-19. For External Use Only. Avoid contacts with eyes. In case of eye contact, flush eyes with water. If irritation or redness develops, stop use. If condition persists for more than 72 hours, contact a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Distributed By: Thor Microbials

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Label

Si + ARMOR
LONG-LASTING ANTIMICROBIAL

HAND SANITIZER

ALCOHOL FREE

KILLS 99.9% OF GERMS &
HUMAN CORONA VIRUS

4-8 HOURS
OF GERM PROTECTION

Softens Hands 200 Applications
1 fl oz ( 30 ml)

MADE IN
USA

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80581-087
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIPROPYLENE GLYCOL (UNII: 3C8845E7C1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80581-087-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M003	09/21/2020

Labeler - QuadSil Inc (168969595)

Establishment
Name	Address	ID/FEI	Business Operations
Tri Pac		020844956	MANUFACTURE(80581-087)