FDA.reportPublic FDA data

Aomi Hand Sanitizer Cleansing Plus

Manufacturer
Mirfeel Korea Co., Ltd
Effective date
2020-04-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:06

Label at a glance#

ProductAomi Hand Sanitizer Cleansing Plus
Active ingredientAlcohol
Label structure10 sections

Indications and uses

Uses Disinfection of hands and skin

Dosage and administration

Directions ■ Please take out adequate amounts of gel on palm of your hand and rub your hands for 15 seconds at least.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: ALCOHOL 70.0% (w/w)

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Water, Carbomer 940, Triethanolamine, Jasminum Officinale (Jasmine) Extract, Prunus Mume Flower Extract, Bellis Perennis (Daisy) Flower Extract, Fragrance

PURPOSE

OTC - PURPOSE SECTION

PURPOSE: ANTISEPTIC

WARNINGS

WARNINGS SECTION

Warnings:

For external use only. Flammable. Keep away from heat or flame
--------------------------------------------------------------------------------------------------------
Do not use
• in children less than 2 months of age
• on open skin wounds
--------------------------------------------------------------------------------------------------------
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
--------------------------------------------------------------------------------------------------------
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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 a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Uses

Disinfection of hands and skin

Directions

DOSAGE & ADMINISTRATION SECTION

Directions
■ Please take out adequate amounts of gel on palm of your hand and rub your hands for 15 seconds at least.

Other Information

OTHER SAFETY INFORMATION

Other Information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809631873302GTIN-13: 8809631873302
EAN-13: 8809631873302
GTIN storage (14 digits): 08809631873302		aomi bottle.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75010-010-012022-01-28C16284748780-1d6a99b39-efba-a426-e053-dadaa90af4c21683c43e-08e2-4b0e-b09b-5e5a94a8feea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75010-010-01Aomi Hand Sanitizer Cleansing Plus500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75010-010AOMI HAND SANITIZER CLEANSING PLUS (ALCOHOL) GEL [MIRFEEL KOREA CO., LTD]1Legacy NDC, 1 package rows20200414_1683c43e-08e2-4b0e-b09b-5e5a94a8feea.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
75010-01075010-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MACTIB
Water059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
JASMINUM OFFICINALE FLOWER0Q8K841432IACT
PRUNUS MUME FLOWER2N8872050JIACT
BELLIS PERENNIS FLOWER26I94X9A1KIACT

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
82d5b325-704d-4f52-b82a-cb259c159e221683c43e-08e2-4b0e-b09b-5e5a94a8feea2020-04-14WarningsExact identifier
spl id: 82d5b325-704d-4f52-b82a-cb259c159e22
spl set id: 1683c43e-08e2-4b0e-b09b-5e5a94a8feea

Reported adverse events (FAERS/openFDA)#

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