FDA.reportPublic FDA data

SAFE HAND CLEAN gel

Manufacturer
ACE PHARMACEUTICAL CO LTD
Effective date
2020-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:10:12

Label at a glance#

ProductSAFE HAND CLEAN gel
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ethanol

INACTIVE INGREDIENT SECTION

Glycerin
Butylene Glycol
Sodium Hyaluronate
Carbomer
Triethanolamine
Fragrance
Camellia Sinensis Leaf Extract
Aloe Barbadensis Leaf Juice
Water

OTC - PURPOSE SECTION

hand sanitizer to help reduce bacteria that potentially can cause disease

for use when soap and water are not available

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.

Dispense appropriate amount on your palm and thoroughly spread on both hands and rub into the skin until dry

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
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74196-0003-12023-01-30C16284748780-1f386c649-e0b5-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74196-0003-1SAFE HAND CLEAN gel500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74196-0003SAFE HAND CLEAN GEL (ALCOHOL) GEL [ACE PHARMACEUTICAL CO LTD]1Legacy NDC, 1 package rows20200508_a50a9c34-383e-9f30-e053-2a95a90a3f64.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
74196-000374196-0003-1

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
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT

Source Document#

Source XML · Source PDF

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
a50a908d-a6e1-93fb-e053-2995a90a5704a50a9c34-383e-9f30-e053-2a95a90a3f642020-05-07WarningsExact identifier
spl id: a50a908d-a6e1-93fb-e053-2995a90a5704
spl set id: a50a9c34-383e-9f30-e053-2a95a90a3f64

Reported adverse events (FAERS/openFDA)#

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