FDA.reportPublic FDA data

Soft Care Sentry

Manufacturer
Diversey, Inc. | KUTOL PRODUCTS COMPANY
Effective date
2018-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:48

Label at a glance#

ProductSoft Care Sentry
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

For hands to decrease bacteria on the skin.

Recommended for repeated use.

WARNINGS SECTION

Warnings

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 in eyes.

In case of 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

Apply a small amount to hands, add water and lather by rubbing hands together for 20 seconds, rinse with potable water.

REFERENCES SECTION

Other information

EMERGENCY PHONE: 1-800-851-7145

See SDS MS0801277

FOR COMMERCIAL USE

See container for Lot Code and Expiry Date.

Store in a cool dry place.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Cocamidopropyl betaine, Cocamidopropyl PG-Dimmonium Chloride Phosphate, Laurtrimonium Chloride, PEG-6 Cocamide, Iodopropynyl Butylcarbamate, Methylisothiazolinone

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

Diversey

NDC 64536-1948-3

Soft Care Sentry

Foaming Antibacterial Hand Soap

For commercial use

NSF

Nonfood Compounds

Program Listed E2

Registration 156691

(L)     Exp.

Net Contents

1.3 L / 1.37 U.S. Qt.

SKU: 101100320

container labelFPM1container labelFPM1

container labelBPM3container labelBPM3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64536-1948-3Soft Care Sentry1300 mL in 1 BOTTLE, PUMPSOLUTION13002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64536-1948SOFT CARE SENTRY (BENZALKONIUM CHLORIDE) SOLUTION [DIVERSEY, INC.]2Current NDC, Legacy NDC, 1 package rows20180301_f0686b7b-2f41-4656-8eb2-09483571a1bc.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64536-194864536-1948-3

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE205Z54J075IACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
PEG-6 COCAMIDEYZ6NLA4O1EIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

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 SentryBENZALKONIUM CHLORIDEDiversey, Inc.f0686b7b-2f41-4656-8eb2-09483571a1bc2018-03-01WarningsExact identifier
ndc (package): 64536-1948-3
ndc (product): 64536-1948
ndc11 (package): 64536194803
spl id: b113e4a1-fdba-4f2a-9800-994b7aa6a924
spl set id: f0686b7b-2f41-4656-8eb2-09483571a1bc

Reported adverse events (FAERS/openFDA)#

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