FDA.reportPublic FDA data

Soft Care Defend Foam Antibacterial Handwash

Manufacturer
Diversey, Inc. | Diversey Canada, Inc.
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:04:23

Label at a glance#

ProductSoft Care Defend Foam Antibacterial Handwash
Active ingredientCHLOROXYLENOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Chloroxylenol 1.0%

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

For handwashing to decrease bacteria on the skin.

For occasional use.

WARNINGS SECTION

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Do not ingest.

OTC - DO NOT USE SECTION

Do not use in the eyes.

OTC - WHEN USING SECTION

When using this product do not get into eyes.

In case of eye contact, immediately flush with water.

OTC - STOP USE SECTION

Stop use and ask a doctor 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.

If swallowed, get medical help or contact a Poison Control center right away.

Do not use if you are allergic to any ingredients

DOSAGE & ADMINISTRATION SECTION

Directions

Wet hands and forearms.

Apply 0.4 mL or 1.0 mL of soap to hands.

Lather hands and forearms for at least 30 seconds, rinse thoroughly with potable water.

Supervise children when they use this product.

REFERENCES SECTION

Other information

EMERGENCY PHONE: 1-800-851-7145

See SDS MS0301548

FOR COMMERCIAL USE.

See container for Lot Code and Expiry Date.

Store in a cool dry place.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Ammonium Lauryl Sulfate, Alcohol Denat, Sodium Lauryl Ether Sulfate, Propylene Glycol, Tetrasodium EDTA, Isopropyl Alcohol

OTC - QUESTIONS SECTION

Questions or comments?

1-800-558-2332 Monday through Friday 7:30 AM to 5:00 PM Central Standard Time

www.diversey.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64536-8308-3

DIN 02448866

Diversey

SoftCare Defend Foam

Antibacterial Handwash

Chloroxylenol Liquid

For commercial use

NSF

Nonfood Compounds

Program listed E2

Registration # 152964

(L) Exp.

U

Net Contents

1.2 L/ 1.27 U.S. Qt.

SKU: 100907902

container labelcontainer label

container labelcontainer label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
413257chloroxylenol 1 % Medicated Liquid SoapPSN8
413257chloroxylenol 10 MG/ML Medicated Liquid SoapSCD8
413257chloroxylenol 1 % Medicated Liquid SoapSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64536-8308-2Soft Care Defend Foam Antibacterial Handwash1200 mL in 1 BOTTLESOLUTION12008
64536-8308-3Soft Care Defend Foam Antibacterial Handwash1200 mL in 1 BOTTLE, PUMPSOLUTION12008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64536-8308SOFT CARE DEFEND FOAM ANTIBACTERIAL HANDWASH (CHLOROXYLENOL) SOLUTION [DIVERSEY, INC.]8Current NDC, Legacy NDC, 2 package rows20231215_801f07c1-6eea-4929-bb27-5768efe5de65.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64536-830864536-8308-2, 64536-8308-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
ISOPROPYL ALCOHOLND2M416302IACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
CHLOROXYLENOL0F32U78V2QACTIB
WATER059QF0KO0RIACT

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
Soft Care Defend Foam Antibacterial HandwashCHLOROXYLENOLDiversey, Inc.801f07c1-6eea-4929-bb27-5768efe5de652023-12-14WarningsExact identifier
ndc (package): 64536-8308-2
ndc (package): 64536-8308-3
ndc (product): 64536-8308
ndc11 (package): 64536830802
ndc11 (package): 64536830803
spl id: 0c6c860a-410f-6633-e063-6294a90a2c31
spl set id: 801f07c1-6eea-4929-bb27-5768efe5de65

Reported adverse events (FAERS/openFDA)#

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