FDA.reportPublic FDA data

Soft Foam Hand Sanitizer

Manufacturer
Freedom Technologies LLC
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:50

Label at a glance#

ProductSoft Foam Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride

OTC - PURPOSE SECTION

Antibacterial

INDICATIONS & USAGE SECTION

Antibacertial foaming hand cleaner. Use in daycare, nursing homes, restaurants, doctors offices, dental offices, schools and clinics

WARNINGS SECTION

For external use only. Avoid contact with eyes. If contact occurs, rinse with water. Discontinue use if irritation or redness develops. If irritation persist for more than 72 hours, consult a physician.

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

Ready to use without dilution. Dispense 1 pump of product onto plalm of hand and rub thoroughly over all surfaces of hands unitl dry.

INACTIVE INGREDIENT SECTION

Water, Decyl Glucoside, Glycerin, DMDM Hydantoin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Soft Foam Hand SanitizerSoft Foam Hand Sanitizer

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80891-234-022022-07-29C16284748780-1e4f33bdf-9e12-d8a0-e053-dadaa90a6e4eSoft Foam Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80891-234-01Soft Foam Hand Sanitizer3780 mg in 1 BOTTLELIQUID37803
80891-234-02Soft Foam Hand Sanitizer1 in 1 BOXLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80891-234SOFT FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [FREEDOM TECHNOLOGIES LLC]3Legacy NDC, 2 package rows20220114_b2990d1f-df96-614f-e053-2a95a90a7539.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80891-23480891-234-01, 80891-234-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
DECYL GLUCOSIDEZ17H97EA6YIACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
DMDM HYDANTOINBYR0546TOWIACT
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
d57eb1b3-06a0-43d5-e053-2a95a90a653db2990d1f-df96-614f-e053-2a95a90a75392022-01-13WarningsExact identifier
spl id: d57eb1b3-06a0-43d5-e053-2a95a90a653d
spl set id: b2990d1f-df96-614f-e053-2a95a90a7539