HYGIENE OF SWEDEN- pocket spray aerosol, spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Benzalkonium Chloride 0,495 g/l

Available from:

Hygiene of Sweden AB

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

HYGIENE OF SWEDEN- POCKET SPRAY AEROSOL, SPRAY
HYGIENE OF SWEDEN AB
_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._
----------
HAND SANITIZER
ACTIVE INGREDIENTS
Benzalkonium Chloride 0,495 g/l
Apply generously to hands and allow it to dry for 60 seconds.
Avoid contact with eyes. If contact occurs, rinse thoroughly with
water.
Purified water, Biopolymer, Aloe Vera, Vitamin B5, Lactic Acid
Antibacterial. Spray on hands and rub, allow 60 seconds to dry.
Antibacterial
N/A
81274-001-01
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 -
BENZ ALKONIUM
9.9 mg
Hygiene of Sweden AB
UNII:7N6JUD5X6Y)
CHLORIDE
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
BUSIN