Jasna Pearl Hand Sanitizer

Manufacturer
ELLA COSMETIC CO., LTD.
Effective date
2020-03-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:04:20

Label at a glance#

ProductJasna Pearl Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Uses: Disinfection of hands and skin

Dosage and administration

Directions: Take an appropriate amount on your hands and rub thoroughly to dry.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: ALCOHOL 62.0%

PURPOSE

OTC - PURPOSE SECTION

Purpose: SANITIZER

WARNINGS

WARNINGS SECTION

Warnings:

For external use only.

1.Do not use the product on the following areas:
Around the eyes and ears, in the mouth, large body parts and damaged skin(Irritation may occur)

2.If you experience any of the following symptoms, discontinue use of the product immediately and consult a physician or pharmacist.
1) Hypersensitivity symptoms, e.g. rash, erythema, itchiness, and edema
2)Skin irritation symptoms

3.Other precautions
1) For external use only (do not swallow).
2) Avoid contact with eyes. If contact occurs, wash with clean water and consult a doctor or pharmacist.
3)Be careful not to inhale vapors in cases of extended or prolonged use. (Repeating inhaling of large amounts of ethanol vapor may cause irritation of the mucous membranes and headaches).
(Limited to ethanol-containing products)
4) If used repeatedly in the same area, care should be provided as the skin may become rough due to excessive oil removal.
5) Do not use sealed bandages, cast bandages, or packs as they may cause irritation.
6) Do not use this drug on the anal or vagina areas, or with hot packs, as it may cause irritation or chemical burns.
7) Use only for the intended purposes.

4.Precautions for storage
1) Keep away from direct sunlight and do not expose the product to heating devices or flame.
2) Keep out of reach of children and go to the hospital immediately if swallowed.
3) After use, close the lid completely to prevent the product from drying or foreign objects from getting inside the container.
4) Storing the product in a different container may cause accidents or deterioration of quality. Therefore, keep the product in its original container.

Dust or foreign substances may get on the product while using it.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and go to the hospital immediately if swallowed.

Uses

INDICATIONS & USAGE SECTION

Uses: Disinfection of hands and skin

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:
Take an appropriate amount on your hands and rub thoroughly to dry.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:
WATER, GLYCERIN, CARBOMER, TRIETHANOLAMINE, BUTYLENE GLYCOL, CAMELLIA SINENSIS LEAF EXTRACT,
GLYCYRRHIZA URALENSIS(LICORICE) ROOT EXTRACT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN2
581660ethanol 0.62 ML/ML Topical GelSCD2
581660ethanol 62 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74003-010-012023-01-30C16284748780-1f386c649-c651-0266-e053-dadaa90a7c1a9a571b9d-d6ee-4944-8564-3e833a684fce

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74003-010-01Jasna Pearl Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74003-010JASNA PEARL HAND SANITIZER (ALCOHOL) GEL [ELLA COSMETIC CO., LTD.]2Legacy NDC, 1 package rows20200331_9a571b9d-d6ee-4944-8564-3e833a684fce.zip

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
74003-01074003-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT

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
d2691a15-5fa1-4e0b-98e8-477bea733d349a571b9d-d6ee-4944-8564-3e833a684fce2020-03-31WarningsExact identifier
spl id: d2691a15-5fa1-4e0b-98e8-477bea733d34
spl set id: 9a571b9d-d6ee-4944-8564-3e833a684fce

Reported adverse events (FAERS/openFDA)#

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