FDA.reportPublic FDA data

Royal Antibacterial Foam Hand Wash

Manufacturer
CWGC LA Inc.
Effective date
2023-09-21
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:04:53

Label at a glance#

ProductRoyal Antibacterial Foam Hand Wash
Active ingredientCHLOROXYLENOL
Label structure6 sections

Indications and uses

For handwashing to reduce bacteria on the skin

Dosage and administration

Apply foaming cleanser to dry hands Rub hands together to spread lather Wash for 15-20 seconds Rinse & dry hands thoroughly

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol, 0.5%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

  • For handwashing to reduce bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes. In case of eye contact, flush with water

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center rihgt away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply foaming cleanser to dry hands
  • Rub hands together to spread lather
  • Wash for 15-20 seconds
  • Rinse & dry hands thoroughly

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Isopropyl Alcohol, Cocamidopropyl Betaine, Decyl Glucoside, SODIUM C14-16 OLEFIN SULFONATE, Hydrogenated castor Oil, DMDM Hydantoin, Citric Acid, Fragrance, FD&C Blue No.1, FD&C Yellow No.5.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Royal Product_Labels_Antibacterial Foam Hand WashRoyal Product_Labels_Antibacterial Foam Hand Wash

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
436367chloroxylenol 0.5 % Medicated Liquid SoapPSN10
436367chloroxylenol 5 MG/ML Medicated Liquid SoapSCD10
436367chloroxylenol 0.5 % Medicated Liquid SoapSY10

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70415-201-012025-01-30C16284748780-10191ceaa-6978-198a-e063-dbdaa90aec3eCWGC (as PLD) - Royal Antibacterial Foam Hand Wash (70415-201)
70415-201-012023-12-18C16284748780-10191ceaa-6978-198a-e063-dbdaa90aec3eCWGC (as PLD) - Royal Antibacterial Foam Hand Wash (70415-201)
70415-201-012023-07-28C16284748780-10191ceaa-6978-198a-e063-dbdaa90aec3eCWGC (as PLD) - Royal Antibacterial Foam Hand Wash (70415-201)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70415-201-01Royal Antibacterial Foam Hand Wash1000 mL in 1 BOTTLESOLUTION100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70415-201ROYAL ANTIBACTERIAL FOAM HAND WASH (CHLOROXYLENOL) SOLUTION [CWGC LA INC.]10Legacy NDC, 1 package rows20231219_f54a9df2-c92e-49bb-9d7c-77a97276ba2d.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70415-20170415-201-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
ISOPROPYL ALCOHOLND2M416302IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
DMDM HYDANTOINBYR0546TOWIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
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
05df627c-b86e-a543-e063-6294a90a28bcf54a9df2-c92e-49bb-9d7c-77a97276ba2d2023-09-21WarningsExact identifier
spl id: 05df627c-b86e-a543-e063-6294a90a28bc
spl set id: f54a9df2-c92e-49bb-9d7c-77a97276ba2d

Reported adverse events (FAERS/openFDA)#

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