FDA.reportPublic FDA data

ANTIMICROBIALSOAP

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 23:40:50

Label at a glance#

ProductANTIMICROBIALSOAP
Active ingredientCHLOROXYLENOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Chloroxylenol 0.75% w/w

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Uses：

  • for hand-washing to decrease microbes on the skin.
  • ideal for daily repeated washing

WARNINGS SECTION

Warnings:

For external use only.

OTC - WHEN USING SECTION

When using this product

  • do not use in or near eyes.

OTC - STOP USE SECTION

  • discotinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • wet hands
  • apply product (palmful)
  • wash hands vigorously
  • rinse thoroughly

OTHER SAFETY INFORMATION

Other information:

  • store at room temperature
  • for healthcare professional use only

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Aloe Barbadensis Leaf Juice, Cocamide MEA, Coco-Betaine, Coconut Fatty Acid, D&C Green No.8, FD&C Blue No.1, FD&C Yellow No.5, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Monoethanolamine, Oleic Acid, Propylene Glycol, Sodium Sulfate, Tetrasodium EDTA, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of hand sanitizer 532mlimage of hand sanitizer 532mlimage of hand sanitizer 3800mlimage of hand sanitizer 3800mlimage of hand sanitizer 800mlimage of hand sanitizer 800mlimage of hand sanitizer 118mlimage of hand sanitizer 118ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1045003chloroxylenol 0.75 % Medicated Liquid SoapPSN1
1045003chloroxylenol 7.5 MG/ML Medicated Liquid SoapSCD1
1045003chloroxylenol 0.75 % Medicated Liquid SoapSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130044600323770GTIN-13: 0044600323770
EAN-13: 0044600323770
GTIN-12: 044600323770
UPC-A: 044600323770
GTIN storage (14 digits): 00044600323770		118ml.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47993-325-012025-01-30C16284748780-12cef2736-63b4-d83d-e063-dadaa90ab31f47993-325
47993-325-022025-01-30C16284748780-12cef2736-63b4-d83d-e063-dadaa90ab31f47993-325
47993-325-032025-01-30C16284748780-12cef2736-63b4-d83d-e063-dadaa90ab31f47993-325
47993-325-042025-01-30C16284748780-12cef2736-63b4-d83d-e063-dadaa90ab31f47993-325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47993-325-01ANTIMICROBIALSOAP118 mL in 1 BOTTLEGEL1181
47993-325-02ANTIMICROBIALSOAP532 mL in 1 BOTTLE, PUMPGEL5321
47993-325-03ANTIMICROBIALSOAP800 mL in 1 BAGGEL8001
47993-325-04ANTIMICROBIALSOAP3800 mL in 1 BOTTLEGEL38001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47993-325ANTIMICROBIALSOAP (CHLOROXYLENOL) GEL [NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD]1Legacy NDC, 4 package rows20210617_69723b40-606f-446f-970f-528e7b85c9ae.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47993-32547993-325-01, 47993-325-02, 47993-325-03, 47993-325-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
COCO MONOETHANOLAMIDEC80684146DIACT
COCO-BETAINE03DH2IZ3FYIACT
COCO DIETHANOLAMIDE92005F972DIACT
D&C GREEN NO. 8I2W85YOX9LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MONOETHANOLAMINE5KV86114PTIACT
OLEIC ACID2UMI9U37CPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM SULFATE0YPR65R21JIACT
EDETATE SODIUMMP1J8420LUIACT
WATER059QF0KO0RIACT
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
c4f12df0-da51-d05b-e053-2a95a90a1a8b69723b40-606f-446f-970f-528e7b85c9ae2021-06-17WarningsExact identifier
spl id: c4f12df0-da51-d05b-e053-2a95a90a1a8b
spl set id: 69723b40-606f-446f-970f-528e7b85c9ae

Reported adverse events (FAERS/openFDA)#

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