FDA.reportPublic FDA data

HYGIENIGEL

Manufacturer
HAIKOWER S.r.l. | MELCHIONNA PLLC
Effective date
2021-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:52:12

Label at a glance#

ProductHYGIENIGEL
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTACTIVE INGREDIENT

OTC - ASK DOCTOR SECTION

Ask doc sectionAsk doc section

OTC - DO NOT USE SECTION

Do not use sectionDo not use section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC keep out of reach of childrenOTC keep out of reach of children

OTC - PURPOSE SECTION

OTC purposeOTC purpose

WARNINGS SECTION

WarningsWarnings

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

DOSAGE FORMS & STRENGTHS SECTION

Dosage sectionDosage section

INDICATIONS & USAGE SECTION

Indication and UsageIndication and Usage

DOSAGE & ADMINISTRATION SECTION

Dosage and Admin.Dosage and Admin.

Package and Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABELPACKAGE LABEL

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78619-01078619-010-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT

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
bc3025d4-4124-5af9-e053-2995a90a76b7bb8bc3ff-113d-a08d-e053-2a95a90acac12021-02-25WarningsExact identifier
spl set id: bb8bc3ff-113d-a08d-e053-2a95a90acac1

Reported adverse events (FAERS/openFDA)#

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