FDA.reportPublic FDA data

WellDerma CLEAN HAND SANITIZER Gel

Manufacturer
PPU CO., LTD | Ester Co., Ltd. | PAMTEK COSMETIC Co., Ltd
Effective date
2021-01-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:36:24

Label at a glance#

ProductWellDerma CLEAN HAND SANITIZER Gel
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol

INACTIVE INGREDIENT SECTION

carbomer 940, butylene glycol, triethanolamine, polysorbate 60, isopropyl myristate, fragrance, 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

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

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 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. 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
581660ethanol 62 % Topical GelPSN4
581660ethanol 0.62 ML/ML Topical GelSCD4
581660ethanol 62 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74999-0001-22022-07-29C16284748780-1e4f33bdf-9c96-d8a0-e053-dadaa90a6e4ePAMTEX COSMETIC Co., Ltd - WELLDERMA CLEAN HAND SANITIZER Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74999-0001-1WellDerma CLEAN HAND SANITIZER Gel2 mL in 1 PACKETGEL24
74999-0001-2WellDerma CLEAN HAND SANITIZER Gel100 in 1 CARTONGEL1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74999-0001WELLDERMA CLEAN HAND SANITIZER GEL (ALCOHOL) GEL [PPU CO., LTD]4Legacy NDC, 2 package rows20210105_a329ab41-2a5e-49ac-e053-2995a90acea0.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
74999-000174999-0001-1, 74999-0001-2

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
POLYSORBATE 60CAL22UVI4MIACT
CARBOMER 9404Q93RCW27EIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
b80a598f-8c70-cc8f-e053-2995a90a31e2a329ab41-2a5e-49ac-e053-2995a90acea02021-01-03WarningsExact identifier
spl id: b80a598f-8c70-cc8f-e053-2995a90a31e2
spl set id: a329ab41-2a5e-49ac-e053-2995a90acea0

Reported adverse events (FAERS/openFDA)#

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