FDA.reportPublic FDA data

Foaming Hand

Manufacturer
SHIBY INC
Effective date
2023-02-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:15

Label at a glance#

ProductFoaming Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Dosage and administration

Wash hands and rinse

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

0.13% Benalkonium chloride

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

helps eliminate bacteria on hands

Warning

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not use in near the eyes. In case of contact, rinse eyes thoroughly with water.

Keep out of reach of children,

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wash hands and rinse

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, Coconut Oil Diethanolamide, Sodium Lauryl Sulfate, Phenoxyethanol, Parfume, Sodium Benzoate, Citric Acid

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN3
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD3
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY3
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82110-001-012024-07-30C16284748780-11030e364-fdc4-111a-e063-dadaa90a10e2Foaming Hand Soap
82110-001-012024-01-30C16284748780-11030e364-fdc4-111a-e063-dadaa90a10e2Foaming Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82110-001-01Foaming Hand3780 mL in 1 BOTTLELIQUID37803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82110-001FOAMING HAND (BENZALKONIUM CHLORIDE) LIQUID [SHIBY INC]3Legacy NDC, 1 package rows20230224_c936af2b-4997-d6da-e053-2995a90aa066.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82110-00182110-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
COCO DIETHANOLAMIDE92005F972DIACT
SODIUM LAURYL SULFATE368GB5141JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
f564a53f-cefa-7160-e053-2995a90a116ec936af2b-4997-d6da-e053-2995a90aa0662023-02-23WarningsExact identifier
spl id: f564a53f-cefa-7160-e053-2995a90a116e
spl set id: c936af2b-4997-d6da-e053-2995a90aa066

Reported adverse events (FAERS/openFDA)#

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