HAND SANITIZER- benzalkonium chloride liquid HAND SANITIZER- benzalkonium chloride spray

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Northmed SIA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride (.20%). Purpose: Antiseptic

PURPOSE

Antiseptic. Hand Sanitizer.

INDICATIONS & USAGE

Sanitizer to help reduce bacteria on hands. Recommended for repeated use.

WARNINGS

For external use only.

STORAGE AND HANDLING

Should not be sotred below 41F/5C or above 104F/40C.

DO NOT USE

Do not use in or near eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

STOP USE

Stop use and ask a doctor if irritation and rendess develop and persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison control center immediately.

DOSAGE & ADMINISTRATION

Apply to hands and rub into the surface of the hands until completely absorbed.

INACTIVE INGREDIENT

Water, Glycerin, Panthenol, Aloe Vera, Tetrasodium Glutamate Diacetate.

PRINCIPAL DISPLAY PANEL

1000 mL (33.8 fl. oz.) NDC: 78522-104-00

2 fl. oz. 59ml. NDC: 78522-100-00

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78522-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	2 mg  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78522-104-00	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/27/2021

HAND SANITIZER 
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78522-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	2 mg  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERIN (UNII: PDC6A3C0OX)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78522-100-00	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/05/2021

Labeler - Northmed SIA (662588132)

Establishment
Name	Address	ID/FEI	Business Operations
Northmed SIA		662588132	manufacture(78522-100, 78522-104) , pack(78522-104) , label(78522-104)