HYGIENE OF SWEDEN- pocket spray aerosol, spray

Hygiene of Sweden by

Drug Labeling and Warnings

Hygiene of Sweden by is a Otc medication manufactured, distributed, or labeled by Hygiene of Sweden AB, Hygiene of Sweden USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzalkonium Chloride 0,495 g/l

DOSAGE & ADMINISTRATION

Apply generously to hands and allow it to dry for 60 seconds.

WARNINGS

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

INACTIVE INGREDIENT

Purified water, Biopolymer, Aloe Vera, Vitamin B5, Lactic Acid

INDICATIONS & USAGE

Antibacterial. Spray on hands and rub, allow 60 seconds to dry.

PURPOSE

Antibacterial

KEEP OUT OF REACH OF CHILDREN

N/A

PRINCIPAL DISPLAY PANEL

81274-001-01

INGREDIENTS AND APPEARANCE

HYGIENE OF SWEDEN 
pocket spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81274-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	9.9 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LACTIC ACID (UNII: 33X04XA5AT)	0.03 mL  in 100 mL
CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S) (UNII: 5GV09YMO52)	0.02 mL  in 100 mL
POLYETHYLENIMINE HYDROCHLORIDE (20000 MW) (UNII: R1Q64CR5FF)	0.01 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.25 mL  in 100 mL
DEXPANTHENOL (UNII: 1O6C93RI7Z)	0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	99.48 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81274-001-01	20 mL in 1 BOTTLE, SPRAY; Type 6: Drug/Biologic Combination	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2020

Labeler - Hygiene of Sweden AB (353008228)

Registrant - Hygiene of Sweden AB (353008228)

Establishment
Name	Address	ID/FEI	Business Operations
Hygiene of Sweden USA LLC		117779651	label(81274-001)

Establishment
Name	Address	ID/FEI	Business Operations
Hygiene of Sweden AB		353008228	manufacture(81274-001)