FDA.reportPublic FDA data

Higienium

Manufacturer
Grande Gloria Production S.A.
Effective date
2021-05-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:44:04

Label at a glance#

ProductHygienium
Active ingredientBENZALKONIUM CHLORIDE, CHLORHEXIDINE GLUCONATE
Label structure9 sections

Label contents#

Full prescribing information#

DOSAGE FORMS & STRENGTHS SECTION

dosage form - liquid

Route of administration- topical

Warnings

WARNINGS SECTION

For external use only, Flammable. Keep away from heat or flame.

INDICATIONS & USAGE SECTION

Use: Product used as antibacterial liquid soap for human hygiene. Skincare and protection

When using this product keep out of eyes, ears, and mouth. In case of constant with eyes, rinse eyes thoroughly with water.

Direction for use: Place enough products on your hands to cover all surfaces. Rub hands together until dry. Apply water.

INACTIVE INGREDIENT SECTION

Inactive ingredients: water, Cocamidopropyl betaine, PEG-200 Glyceryl, PEG-7 Glyceryl, Lauryl glucoside, Gossypium extract, Parfum

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use in children less than 2 months of age. Keep out of children's reach, except under adult supervision. If swallowed get medical help or contact a poison control center right away.

OTC - PURPOSE SECTION

Use for human hygiene. Antibacterial hand soap

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 1% v/v- antiseptic

Chlorhexidine Digluconate 0.4%v/v- antiseptic

DOSAGE & ADMINISTRATION SECTION

300ml

Do not use in children less than 2 months of age and on open wounds. Please enough product on hands to cover all surface. Supervise children under 6 years of age when using this product.

Antibacterial liquid soap

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antibacterial liquid soapAntibacterial liquid soap1% benzalkonium chloride

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81592-167981592-1679-4, 81592-1679-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
COCO-BETAINE03DH2IZ3FYIACT
PEG-200 HYDROGENATED GLYCERYL PALMATEW161T051Y1IACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB
WATER059QF0KO0RIACT

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
d474c6d3-4203-96d1-e053-2995a90a24d9bedc2209-ee2e-746a-e053-2995a90a147d2021-12-31WarningsExact identifier
spl set id: bedc2209-ee2e-746a-e053-2995a90a147d

Reported adverse events (FAERS/openFDA)#

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