FDA.reportPublic FDA data

Hygienigel Gel - 70%

Manufacturer
HAIKOWER S.r.l. | MELCHIONNA PLLC
Effective date
2021-03-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:38:42

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

Carbomer, Dmdm Hydantoin, Ethylhexylglycerin, Fragrance, Melaleuca Alternifolia Leaf Oil, Panthenol, Peg/ppg-14/4 Dimethicone, Peg-60 Lanolin, Propylene Glycol, Phenoxyethanol, Triethanolamine, Water

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

OTC - Ask Doctor

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 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

OTC - Stop use

OTC - STOP USE SECTION

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

Warnings

WARNINGS SECTION

Flammable.

Keep away from flame and fire.

For external use only.

Indication and USage

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78619-200-022022-07-29C16284748780-1e4f33bdf-b3d2-d8a0-e053-dadaa90a6e4eHygienigel Gel - 70%
78619-200-032022-07-29C16284748780-1e4f33bdf-b3d2-d8a0-e053-dadaa90a6e4eHygienigel Gel - 70%
78619-200-042022-07-29C16284748780-1e4f33bdf-b3d2-d8a0-e053-dadaa90a6e4eHygienigel Gel - 70%
78619-200-052022-07-29C16284748780-1e4f33bdf-b3d2-d8a0-e053-dadaa90a6e4eHygienigel Gel - 70%
78619-200-062022-07-29C16284748780-1e4f33bdf-b3d2-d8a0-e053-dadaa90a6e4eHygienigel Gel - 70%
78619-200-072022-07-29C16284748780-1e4f33bdf-b3d2-d8a0-e053-dadaa90a6e4eHygienigel Gel - 70%
78619-200-082022-07-29C16284748780-1e4f33bdf-b3d2-d8a0-e053-dadaa90a6e4eHygienigel Gel - 70%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78619-200-02HYGIENIGEL30 mL in 1 POUCHGEL303
78619-200-03HYGIENIGEL70 mL in 1 POUCHGEL703
78619-200-04HYGIENIGEL100 mL in 1 BOTTLE, PLASTICGEL1003
78619-200-05HYGIENIGEL500 mL in 1 BOTTLE, PLASTICGEL5003
78619-200-06HYGIENIGEL1000 mL in 1 BOTTLE, PLASTICGEL10003
78619-200-07HYGIENIGEL5000 mL in 1 CANGEL50003
78619-200-08HYGIENIGEL2 mL in 1 POUCHGEL23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78619-200HYGIENIGEL (HAND SANITIZER) GEL [HAIKOWER S.R.L.]3Legacy NDC, 7 package rows20210303_bc32a828-3fd4-4494-e053-2a95a90a596a.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78619-20078619-200-07, 78619-200-06, 78619-200-05, 78619-200-04, 78619-200-03, 78619-200-02, 78619-200-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYLGLYCERIN147D247K3PIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
LANOLIN7EV65EAW6HIACT
TRIETHANOLAMINE LAURATE9403LC9W1JIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARBOMER 1342809Y72KV36IACT
FRAGRANCE LEMON ORC2001060K1725A7G95IACT
PANTHENOLWV9CM0O67ZIACT
PEG/PPG-14/4 DIMETHICONE646XNV22YXIACT
PROPYLENE GLYCOL 1-LAURATEM4AW13H75TIACT
DMDM HYDANTOINBYR0546TOWIACT
ALCOHOL3K9958V90MACTIB

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
bc911eb3-52d8-c42d-e053-2995a90a02b4bc32a828-3fd4-4494-e053-2a95a90a596a2021-03-02WarningsExact identifier
spl id: bc911eb3-52d8-c42d-e053-2995a90a02b4
spl set id: bc32a828-3fd4-4494-e053-2a95a90a596a

Reported adverse events (FAERS/openFDA)#

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