FDA.reportPublic FDA data

Triclosan Free Antibacterial 7.5 oz (Ocean)

Manufacturer
Rejoice International Corp. | China Ningbo Shangge Cosmetic Technology Corp.
Effective date
2025-02-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:37

Label at a glance#

ProductTriclosan Free Antibacterial 7.5 oz (Ocean) Antibacterial
Active ingredientCHLOROXYLENOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Purpose

Antibacterial

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Chloroexylenol, 0.3%

INDICATIONS & USAGE SECTION

USAGE

For hand washing to decrease bacteria on the skin

DOSAGE & ADMINISTRATION SECTION

Directions

Pump into hands

Lather vigorously for at least 15 seconds

Rinse and dry thoroughly

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.

WARNINGS SECTION

Warnings


For external use only

When using this product avoid contact with eyes; in case of eye contact, flush with water

Stop use and ask a doctor if irritation and redness develops

INACTIVE INGREDIENT SECTION

WATER, SODIUM LAURETH SULFATE, COCAMIDE MEA, SODIUM C14-16 OLEFIN SULFONATE, SODIUM CHLORIDE, PEG-150 DISTEARATE, FRAGRANCE, CITRIC ACID, GLYCERIN, PEG-40 HYDROGENATED CASTOR OIL, DISODIUM EDTA, TOCOPHERYL ACETATE, METHYLCHLOROTHIAZOLINONE, METHYLISOTHIAZOLINONE, FD&C YELLOW NO.5, D&C RED NO. 33; FD&C BLUE NO. 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN3
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD3
413261chloroxylenol 0.3 % Medicated Liquid SoapSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-088-012025-02-06C16284748780-12cef2736-998e-d83d-e063-dadaa90ab31fTriclosan Free Antibacterial 7.5 oz (Ocean)
57337-088-012025-01-30C16284748780-12cef2736-998e-d83d-e063-dadaa90ab31fTriclosan Free Antibacterial 7.5 oz (Ocean)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-088-01Triclosan Free Antibacterial 7.5 oz (Ocean)Antibacterial221 mL in 1 BOTTLELIQUID2213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-088TRICLOSAN FREE ANTIBACTERIAL 7.5 OZ (OCEAN) ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [REJOICE INTERNATIONAL CORP.]3Current NDC, Legacy NDC, 1 package rows20250209_5160c9e0-cae5-66e2-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57337-08857337-088-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
D&C RED NO. 339DBA0SBB0LIACT
GLYCERINPDC6A3C0OXIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
CHLOROXYLENOL0F32U78V2QACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
COCO MONOETHANOLAMIDEC80684146DIACT
SODIUM CHLORIDE451W47IQ8XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
Triclosan Free Antibacterial 7.5 oz (Ocean) AntibacterialCHLOROXYLENOLRejoice International Corp.5160c9e0-cae5-66e2-e054-00144ff88e882025-02-06WarningsExact identifier
ndc (package): 57337-088-01
ndc (product): 57337-088
ndc11 (package): 57337008801
spl id: 2d763fe8-b777-3120-e063-6294a90a217e
spl set id: 5160c9e0-cae5-66e2-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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