FDA.reportPublic FDA data

Hygiene of Sweden

Manufacturer
Hygiene of Sweden AB | Hygiene of Sweden USA LLC
Effective date
2022-03-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:02

Label at a glance#

ProductHygiene of Sweden
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0,495 g/l

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - PURPOSE SECTION

Antibacterial

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

N/A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

81274-001-01 20 ml20 ml 20 ml20 ml

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81274-001-012024-07-30C16284748780-1d6a99b39-4c33-a426-e053-dadaa90af4c2Hand sanitizer
81274-001-012024-01-30C16284748780-1d6a99b39-4c33-a426-e053-dadaa90af4c2Hand sanitizer
81274-001-012022-04-01C16284748780-1d6a99b39-4c33-a426-e053-dadaa90af4c2Hand sanitizer
81274-001-012022-01-28C16284748780-1d6a99b39-4c33-a426-e053-dadaa90af4c2Hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81274-001-01Hygiene of Sweden20 mL in 1 BOTTLE, SPRAYAEROSOL, SPRAY202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81274-001HYGIENE OF SWEDEN (POCKET SPRAY) AEROSOL, SPRAY [HYGIENE OF SWEDEN AB]2Legacy NDC, 1 package rows20220402_b5f1442d-ad3a-cde0-e053-2995a90ae040.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81274-00181274-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LACTIC ACID33X04XA5ATIACT
CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S)5GV09YMO52IACT
POLYETHYLENIMINE HYDROCHLORIDE (20000 MW)R1Q64CR5FFIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DEXPANTHENOL1O6C93RI7ZIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d650e2ad-dd1c-736a-e053-2995a90a8ce1b5f1442d-ad3a-cde0-e053-2995a90ae0402022-03-18WarningsExact identifier
spl id: d650e2ad-dd1c-736a-e053-2995a90a8ce1
spl set id: b5f1442d-ad3a-cde0-e053-2995a90ae040

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.