FDA.reportPublic FDA data

Justhuman 24 Hour Protection Foam Hand Sanitizer

Manufacturer
Swanrose Inc. | SmartScience Laboratories, Inc
Effective date
2021-02-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:38:12

Label at a glance#

ProductJusthuman 24 Hour Protection Foam Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure17 sections

Indications and uses

For handwashing to decrease bacteria on the skin that can potentially cause disease. Recommended for repeated use.

Dosage and administration

Apply liberally to the hands and gently rub until dry. Just Human Hand Sanitizer will remain active on hands up to 24 hours - even after normal activity and washing hands.

Storage and handling

Store at temperature 68°F to 86°F (20° to 30°C) Advanced Antiseptic \ Skin Freindly \ Alcohol-Free Hand Sanitizer

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%............................Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

USES:

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin that can potentially cause disease.

Recommended for repeated use.

WARNINGS

WARNINGS SECTION

  • FOR EXTERNAL USE ONLY
  • DO NOT USE IN THE EYES

WHEN USING THS PRODUCT:

OTC - WHEN USING SECTION

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

STOP USE AND ASK A DOCTOR IF:

OTC - STOP USE SECTION

  • Rash or irritation develops and lasts more than 24 hrs.

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 immediately.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally to the hands and gently rub until dry. Just Human Hand Sanitizer will remain active on hands up to 24 hours - even after normal activity and washing hands.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Fragrance, Silica Complex 3-(Trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride, Water

OTHER INFORMATION:

STORAGE AND HANDLING SECTION

Store at temperature 68°F to 86°F (20° to 30°C)

Advanced Antiseptic \ Skin Freindly \ Alcohol-Free Hand Sanitizer

FOR QUESTIONS:

OTC - QUESTIONS SECTION

Call +1(323-868-3394

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2oz pink2oz pink

2oz blue2oz blue

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4oz pink4oz pink

4oz blue4oz blue

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8oz pink8oz pink

8oz blue8oz blue

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10ml pink10ml pink

10ml blue10ml blue

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8oz refill8oz refill

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1gal pink1gal pink

1gal blue1gal blue

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN3
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD3
1020365benzalkonium chloride 0.13 % Topical FoamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78287-250-012023-01-30C16284748780-1f386c649-f7ec-0266-e053-dadaa90a7c1a64ca94e1-1e74-4df2-8151-0a436c4cec8c
78287-250-022023-01-30C16284748780-1f386c649-f7ec-0266-e053-dadaa90a7c1a64ca94e1-1e74-4df2-8151-0a436c4cec8c
78287-250-032023-01-30C16284748780-1f386c649-f7ec-0266-e053-dadaa90a7c1a64ca94e1-1e74-4df2-8151-0a436c4cec8c
78287-250-042023-01-30C16284748780-1f386c649-f7ec-0266-e053-dadaa90a7c1a64ca94e1-1e74-4df2-8151-0a436c4cec8c
78287-250-052023-01-30C16284748780-1f386c649-f7ec-0266-e053-dadaa90a7c1a64ca94e1-1e74-4df2-8151-0a436c4cec8c
78287-250-062023-01-30C16284748780-1f386c649-f7ec-0266-e053-dadaa90a7c1a64ca94e1-1e74-4df2-8151-0a436c4cec8c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78287-250-01Justhuman 24 Hour Protection Foam Hand Sanitizer0.06 kg in 1 BOTTLE, PUMPSOLUTION0.063
78287-250-02Justhuman 24 Hour Protection Foam Hand Sanitizer0.120 kg in 1 BOTTLE, PUMPSOLUTION0.1203
78287-250-03Justhuman 24 Hour Protection Foam Hand Sanitizer0.240 kg in 1 BOTTLE, PUMPSOLUTION0.2403
78287-250-04Justhuman 24 Hour Protection Foam Hand Sanitizer0.01 kg in 1 PACKETSOLUTION0.013
78287-250-05Justhuman 24 Hour Protection Foam Hand Sanitizer0.240 kg in 1 BOTTLESOLUTION0.2403
78287-250-06Justhuman 24 Hour Protection Foam Hand Sanitizer3.785 kg in 1 JUGSOLUTION3.7853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78287-250JUSTHUMAN 24 HOUR PROTECTION FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [SWANROSE INC.]3Legacy NDC, 6 package rows20210219_64ca94e1-1e74-4df2-8151-0a436c4cec8c.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78287-25078287-250-01, 78287-250-02, 78287-250-03, 78287-250-04, 78287-250-05, 78287-250-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDEIQ36O85WQ4IACT
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
c569fec0-ddb5-4308-a34c-02a82e1c09de64ca94e1-1e74-4df2-8151-0a436c4cec8c2021-02-18WarningsExact identifier
spl id: c569fec0-ddb5-4308-a34c-02a82e1c09de
spl set id: 64ca94e1-1e74-4df2-8151-0a436c4cec8c

Reported adverse events (FAERS/openFDA)#

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