FDA.reportPublic FDA data

SUNGSU Clean Hand Sanitizer

Manufacturer
SUNGSUBIOTEK CO. LTD.
Effective date
2020-09-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:06

Label at a glance#

ProductSUNGSU Clean Hand Sanitizer
Active ingredientAlcohol
Label structure9 sections

Indications and uses

• Hand sanitizer to help reduce bacteria that potentially can cause disease. • For use when soap and water are not available.

Dosage and administration

• 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62% v/v

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Extract, Butylene Glycol, CARBOMER, DL-Panthenol, Polyoxyethylene Hydrogenetated Caster Oil, Triethanolamine, Water

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

WARNINGS

WARNINGS SECTION

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

• Hand sanitizer to help reduce bacteria that potentially can cause disease.
• For use when soap and water are not available.

Directions

DOSAGE & ADMINISTRATION 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.

Other information

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80454-030-012022-01-28C16284748780-1d6a99b39-7b48-a426-e053-dadaa90af4c28b1bf2e6-bcc6-4cc5-9fcb-72cb0d333451

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80454-030-01SUNGSU Clean Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80454-030SUNGSU CLEAN HAND SANITIZER (ALCOHOL) GEL [SUNGSUBIOTEK CO. LTD.]1Legacy NDC, 1 package rows20200912_8b1bf2e6-bcc6-4cc5-9fcb-72cb0d333451.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
80454-03080454-030-01

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
ALOEV5VD430YW9IACT
Butylene Glycol3XUS85K0RAIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PANTHENOLWV9CM0O67ZIACT
TROLAMINE9O3K93S3TKIACT
Water059QF0KO0RIACT

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
f8c54262-7be1-4823-9644-2952b20b51d28b1bf2e6-bcc6-4cc5-9fcb-72cb0d3334512020-09-11WarningsExact identifier
spl id: f8c54262-7be1-4823-9644-2952b20b51d2
spl set id: 8b1bf2e6-bcc6-4cc5-9fcb-72cb0d333451

Reported adverse events (FAERS/openFDA)#

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