FDA.reportPublic FDA data

Soft Care Foam Instant Hand Sanitizer

Manufacturer
Diversey, Inc. | Kutol Products Company, Inc.
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:57

Label at a glance#

ProductSoft Care Foam Instant Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Ethyl alcohol 62% v/v

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses:

For hands to decrease bacteria on the skin.

Recommended for repeated 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.

When using this product do not get into the eyes.

In case of contact, immediately flush with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or 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.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply 1-2 ml into hands, rub product vigorously over hands covering all surfaces.

Allow to air dry - do not rinse.

REFERENCES SECTION

Other information:

EMERGENCY PHONE: 1-800-851-7145

See SDS MS0301383

Store below 35 C (95 F)

See container for Lot Code and Expiry Date

Do not contaminate water, food or feed during use, storage or disposal.

For Commercial and Industrial Use Only

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, PEG-10 Dimethicone, Glycerin, Isopropyl Myristate, Polyquaternium-11, Disodium EDTA, Aloe Barbabensis Leaf Juice, Tocopheryl Acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

container label 532DL2container label 532DL2container label 50DL2container label 50DL2

NDC 64536-7295-4

Diversey

SoftCare

Foam Instant

Hand Sanitizer

Kills 99.9% of germs and bacteria

Aloe and Vitamin E to moisturize

Contains alcohol

Clean

Protect

Refresh

Net Contents

532 mL/1.12 U.S. Pt.

SKU: 100930835

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616763ethanol 62 % Topical FoamPSN3
616763ethanol 0.62 ML/ML Topical FoamSCD3
616763ethanol 62 % Topical FoamSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64536-7295-4Soft Care Foam Instant Hand Sanitizer532 mL in 1 BOTTLELIQUID5323
64536-7295-5Soft Care Foam Instant Hand Sanitizer50 mL in 1 BOTTLELIQUID503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64536-7295SOFT CARE FOAM INSTANT HAND SANITIZER (ALCOHOL) LIQUID [DIVERSEY, INC.]3Current NDC, Legacy NDC, 2 package rows20241218_674e63ec-445b-4b7a-af15-63d9d624cf1a.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
64536-729564536-7295-5, 64536-7295-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYQUATERNIUM-11 (1000000 MW)0B44BS5IJSIACT
EDETATE DISODIUM7FLD91C86KIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB

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 Foam Instant Hand SanitizerALCOHOLDiversey, Inc.674e63ec-445b-4b7a-af15-63d9d624cf1a2024-12-16WarningsExact identifier
ndc (package): 64536-7295-4
ndc (package): 64536-7295-5
ndc (product): 64536-7295
ndc11 (package): 64536729505
ndc11 (package): 64536729504
spl id: 296a179b-1697-244d-e063-6294a90a4c7c
spl set id: 674e63ec-445b-4b7a-af15-63d9d624cf1a

Reported adverse events (FAERS/openFDA)#

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