FDA.reportPublic FDA data

FOAM-BAC Antibacterial Hand

Manufacturer
Whisk Products, Inc.
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:52:56

Label at a glance#

ProductFOAM-BAC Antibacterial Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Apply a palmful to hands and forearms. Scrub thoroughly for at least fifteen seconds. Rinse completely and dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Skin Antimicrobial

Use

INDICATIONS & USAGE SECTION

reduces amount of bacteria on hands

Warnings

WARNINGS SECTION

For external use only.

When using this product avoid contact with eyes.  In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply a palmful to hands and forearms.
  • Scrub thoroughly for at least fifteen seconds.
  • Rinse completely and dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate, DMDM Hydantoin, Citric Acid, Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Case Label - 8 x 1000 mL BagsCase Label - 8 x 1000 mL Bags

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapPSN4
1233282benzalkonium chloride 1 MG/ML Medicated Liquid SoapSCD4
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65585-521-01FOAM-BAC Antibacterial Hand8 in 1 BOXSOAP84
65585-521-01FOAM-BAC Antibacterial Hand1000 mL in 1 BAGSOAP10004
65585-521-02FOAM-BAC Antibacterial Hand6 in 1 BOXSOAP64
65585-521-02FOAM-BAC Antibacterial Hand550 mL in 1 BOTTLE, PUMPSOAP5504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65585-521FOAM-BAC ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [WHISK PRODUCTS, INC.]4Current NDC, Legacy NDC, 4 package rows20250117_f7ab10b8-1750-436f-a762-6d4d2ca52242.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65585-52165585-521-01, 65585-521-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DMDM HYDANTOINBYR0546TOWIACT
WATER059QF0KO0RIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
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
FOAM-BAC Antibacterial HandBENZALKONIUM CHLORIDEWhisk Products, Inc.f7ab10b8-1750-436f-a762-6d4d2ca522422025-01-15WarningsExact identifier
ndc (package): 65585-521-02
ndc (package): 65585-521-01
ndc (product): 65585-521
ndc11 (package): 65585052102
ndc11 (package): 65585052101
spl id: 2bc46854-fe62-782b-e063-6294a90a79af
spl set id: f7ab10b8-1750-436f-a762-6d4d2ca52242

Reported adverse events (FAERS/openFDA)#

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