FDA.reportPublic FDA data

HANDSOAP

Manufacturer
NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD
Effective date
2021-06-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:52

Label at a glance#

ProductHANDSOAP
Active ingredientCHLOROXYLENOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Chloroxylenol 0.3% 

OTC - PURPOSE SECTION

Antibacterial

INDICATIONS & USAGE SECTION

Use for handwashing to decrease bacteria on the skin.

WARNINGS SECTION

Warnings:

For external use only: hands only.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse eyes with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours.

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.

DOSAGE & ADMINISTRATION SECTION

Directions:

Apply onto wet hands, lather for at least 30 seconds and rinse thoroughly.

OTHER SAFETY INFORMATION

Other information:

Avoid freezing and excessive heat above 40℃ (104℉).

INACTIVE INGREDIENT SECTION

Inactive ingredients:

WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, GLYCERIN, COCAMIDE METHYL MEA, SODIUM CHLORIDE, PARFUM, CHLOROXYLENOL, CITRIC ACID, DISODIUM EDTA, METHYLCHLOROISOTHIAZOLINONE AND METHYLISOTHIAZOLINONE, DYE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of hand sanitizer 473ml-3image of hand sanitizer 473ml-3image of hand sanitizer 473ml-2image of hand sanitizer 473ml-2image of hand sanitizer 1000ml-1image of hand sanitizer 1000ml-1image of hand sanitizer 1000ml-2image of hand sanitizer 1000ml-2image of hand sanitizer 1000ml-3image of hand sanitizer 1000ml-3image of hand sanitizer 473ml-1image of hand sanitizer 473ml-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN1
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD1
413261chloroxylenol 0.3 % Medicated Liquid SoapSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130742797910819GTIN-13: 0742797910819
EAN-13: 0742797910819
GTIN-12: 742797910819
UPC-A: 742797910819
GTIN storage (14 digits): 00742797910819		473ml-3.jpg
BarcodeEAN-130742797910826GTIN-13: 0742797910826
EAN-13: 0742797910826
GTIN-12: 742797910826
UPC-A: 742797910826
GTIN storage (14 digits): 00742797910826		473ml-1.jpg
BarcodeEAN-130742797910833GTIN-13: 0742797910833
EAN-13: 0742797910833
GTIN-12: 742797910833
UPC-A: 742797910833
GTIN storage (14 digits): 00742797910833		473ml-2.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47993-326-012025-01-30C16284748780-12cef2736-9c58-d83d-e063-dadaa90ab31f47993-326
47993-326-022025-01-30C16284748780-12cef2736-9c58-d83d-e063-dadaa90ab31f47993-326

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47993-326-01HANDSOAP473 mL in 1 BOTTLE, PUMPGEL4731
47993-326-02HANDSOAP1000 mL in 1 BAGGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47993-326HANDSOAP (CHLOROXYLENOL) GEL [NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD]1Legacy NDC, 2 package rows20210617_c4fbbda4-69cf-48e9-96f9-0aeb9ef51404.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47993-32647993-326-01, 47993-326-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
COCOYL METHYL MONOETHANOLAMINE79G1T427CFIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
CHLOROXYLENOL0F32U78V2QACTIB

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
c4f1422b-b877-5f56-e053-2a95a90ab2cec4fbbda4-69cf-48e9-96f9-0aeb9ef514042021-06-17WarningsExact identifier
spl id: c4f1422b-b877-5f56-e053-2a95a90ab2ce
spl set id: c4fbbda4-69cf-48e9-96f9-0aeb9ef51404

Reported adverse events (FAERS/openFDA)#

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