FDA.reportPublic FDA data

Modesa

Manufacturer
Family Dollar Services Inc.
Effective date
2017-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:05:51

Label at a glance#

ProductModesa Moisturizing Hand ANTIBACTERIAL
Active ingredientBENZETHONIUM CHLORIDE
Label structure10 sections

Dosage and administration

■ apply onto wet hands, lather and rinse thoroughly

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzethonium chloride 0.10%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

for hand washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

■ avoid contact with the eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION


■ irritation and redness develops

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ apply onto wet hands, lather and rinse thoroughly

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, lauramine oxide, cetrimonium chloride, cocamidopropylamine oxide, cocamide MEA, glycerin, PEG-150 distearate, sodium chloride, fragrance, citric acid, sodium benzoate, tetrasodium EDTA, FD&C blue no.1, D&C red no.33

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package labelPackage label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130032251380655GTIN-13: 0032251380655
EAN-13: 0032251380655
GTIN-12: 032251380655
UPC-A: 032251380655
GTIN storage (14 digits): 00032251380655		MdsaBrndBZKHS.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-431-402021-07-23C16284748780-1c7ccaba7-0e67-fd44-e053-dadaa90aa01bDrug Facts
55319-431-752021-07-23C16284748780-1c7ccaba7-0e67-fd44-e053-dadaa90aa01bDrug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-431MODESA MOISTURIZING HAND ANTIBACTERIAL (BENZETHONIUM CHLORIDE) LIQUID [FAMILY DOLLAR SERVICES INC.]1Legacy NDC20171226_6141e1ac-4f44-35b1-e053-2991aa0a6895.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-43155319-431-75, 55319-431-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
D&C RED NO. 339DBA0SBB0LIACT
GLYCERINPDC6A3C0OXIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
COCO MONOETHANOLAMIDEC80684146DIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
EDETATE SODIUMMP1J8420LUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB

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
6141e157-0068-4f58-e053-2991aa0ad75f6141e1ac-4f44-35b1-e053-2991aa0a68952017-12-26WarningsExact identifier
spl id: 6141e157-0068-4f58-e053-2991aa0ad75f
spl set id: 6141e1ac-4f44-35b1-e053-2991aa0a6895

Reported adverse events (FAERS/openFDA)#

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