FDA.reportPublic FDA data

Soft Care Impact Alcohol Fee Instant Hand Sanitizer

Manufacturer
Diversey, Inc. | Diversey Canada, Inc.
Effective date
2016-09-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:22:53

Label at a glance#

ProductSoft Care Impact Alcohol Fee Instant Hand Sanitizer
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

Antiseptic/Antibacterial cleanser to decrease bacteria on the skin.

For occasional use.

WARNINGS SECTION

Warnings

For external use only.

Do not ingest

Do not use in the eyes.

OTC - WHEN USING SECTION

When using this product

do not use in the 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

Apply 0.4-1ml into hands.

Rub thoroughly into hands for at least 30 seconds.

Allow to dry.

Supervise children when using this product.

REFERENCES SECTION

Other information

EMERGENCY PHONE: 1-800-851-7145

See SDS MS0301542

FOR COMMERCIAL USE.

See container for Lot Code and Expiry Date.

Store in a cool dry place.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water (Aqua), Phenoxyethanol, Propylene Glycol, Glycerin, Tetrasodium EDTA, Cocamidopropyl betaine, Lauramine oxide, Citric acid

OTC - QUESTIONS SECTION

Questions or comments?

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

www.sealedair.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64536-8398-3

DIN 02449412

Sealed Air

Diversery Care

Diversey

Soft Care

Impact Alcohol Free

Instant Hand Sanitizer

Benzalkonium Chloride Liquid

For commercial use

(L)        Exp.

Net Contents

1.3 L / 1.37 U.S. Qt.

100907875

container labelFP1container labelFP1

container labelBP1container labelBP1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64536-8398-32023-11-09C16284748780-19d75b9cf-f45b-f424-e053-dadaa90a57ceDrug Facts
64536-8398-32020-01-31C16284748780-19d75b9cf-f45b-f424-e053-dadaa90a57ceDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64536-839864536-8398-3

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
EDETATE SODIUMMP1J8420LUIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
09b8bdf5-71e3-ec54-e063-6294a90a489f1db2d206-3667-4dbe-84d1-7cc1943fa8642023-11-09WarningsExact identifier
spl set id: 1db2d206-3667-4dbe-84d1-7cc1943fa864

Reported adverse events (FAERS/openFDA)#

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