FDA.reportPublic FDA data

Dr. LIBEAUTE HAND SANITIZER

Manufacturer
Ongoong Co Ltd
Effective date
2020-06-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:18:29

Label at a glance#

ProductDr. LIBEAUTE HAND SANITIZER
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ethyl alcohol

INACTIVE INGREDIENT SECTION

Water, Glycerin, tocopheryl acetate, etc.

OTC - PURPOSE SECTION

Antiseptic

instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

instant hand antiseptic to decrease bacteria on the skin
recommended for repeated use

hand sanitizer to help reduce bacteria on the skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE SECTION

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

WARNINGS SECTION

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286295ethanol 75 % Topical SprayPSN3
2286295ethanol 0.75 ML/ML Topical SpraySCD3
2286295ethanol 75 % Topical SpraySY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74084-0008-12023-01-30C16284748780-1f386c649-bf82-0266-e053-dadaa90a7c1aDrug Facts
74084-0008-22023-01-30C16284748780-1f386c649-bf82-0266-e053-dadaa90a7c1aDrug Facts
74084-0008-32023-01-30C16284748780-1f386c649-bf82-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74084-0008-1Dr. LIBEAUTE HAND SANITIZER500 mL in 1 BOTTLESPRAY5003
74084-0008-2Dr. LIBEAUTE HAND SANITIZER100 mL in 1 BOTTLESPRAY1003
74084-0008-3Dr. LIBEAUTE HAND SANITIZER300 mL in 1 BOTTLESPRAY3003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74084-0008DR. LIBEAUTE HAND SANITIZER (ALCOHOL) SPRAY [ONGOONG CO LTD]3Legacy NDC, 3 package rows20200622_a3763491-269c-e8c5-e053-2a95a90aff8c.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74084-000874084-0008-1, 74084-0008-2, 74084-0008-3

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
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
a8961129-eb8b-9732-e053-2a95a90ac583a3763491-269c-e8c5-e053-2a95a90aff8c2020-06-21WarningsExact identifier
spl id: a8961129-eb8b-9732-e053-2a95a90ac583
spl set id: a3763491-269c-e8c5-e053-2a95a90aff8c

Reported adverse events (FAERS/openFDA)#

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