Hygienigel 75% Spray

Manufacturer
HAIKOWER S.r.l. | MELCHIONNA PLLC
Effective date
2021-02-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:37

Label at a glance#

ProductHygienigel
Active ingredientALCOHOL
Label structure11 sections

Label contents#

Full prescribing information#

Dosage and Admin

DOSAGE & ADMINISTRATION SECTION

Place enough HYGIENIGEL on your hands and rub them until dry.

Children under 6 years of age must be supervised when using HYGIENIGEL.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Melaleuca Alternifolia Leaf Oil, Chlorhexidine Digluconate, Grlycerin, BEnzalkonium Chloride

OTC - Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% v/v

OTC - Ask Doctor section

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - Do not use

OTC - DO NOT USE SECTION

When using this product, do not ingest, inhale or use in or near the eyes. In case of contact, rinse thoroughly with water for at least 2 minutes.

OTC - Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact the Poison Control Center right away.

OTC - Purpose

OTC - PURPOSE SECTION

Uses Hand Sanitizer to help reduce bacteria on the skin

Indication and usage

INDICATIONS & USAGE SECTION

Uses Hand Sanitizer to help reduce bacteria on the skin

OTC _ Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

When using this product, do not ingest, inhale or use in or near the eyes. In case of contact, rinse thoroughly with water for at least 2 minutes.

Warnings

WARNINGS SECTION

- Flammable.

- Keep away from flame and fire.

- For external use only.

Package and Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABELPACKAGE LABEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78619-100-012022-07-29C16284748780-1e4f33bdf-9bdc-d8a0-e053-dadaa90a6e4eHygienigel 75% Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78619-100-01Hygienigel100 mL in 1 BOTTLE, PLASTICSOLUTION, GEL FORMING / DROPS1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78619-100HYGIENIGEL (HAND SANITIZER) SOLUTION, GEL FORMING / DROPS [HAIKOWER S.R.L.]1Legacy NDC, 1 package rows20210227_bc43b659-d56a-3d4b-e053-2a95a90a1de5.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78619-10078619-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
bc43b659-d56b-3d4b-e053-2a95a90a1de5bc43b659-d56a-3d4b-e053-2a95a90a1de52021-02-26WarningsExact identifier
spl id: bc43b659-d56b-3d4b-e053-2a95a90a1de5
spl set id: bc43b659-d56a-3d4b-e053-2a95a90a1de5

Reported adverse events (FAERS/openFDA)#

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