FDA.reportPublic FDA data

Hand Santizer

Manufacturer
Robert Mazza, Inc dba Five & 20 Spirits | Robert Mazza, Inc.
Effective date
2020-04-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:07:19

Label at a glance#

ProductHand Santizer
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

For topical use only

OTC - ACTIVE INGREDIENT SECTION

Alcohol - 80%ABV

INACTIVE INGREDIENT SECTION

Glycerin, Hydrogen Peroxide, Water

INDICATIONS & USAGE SECTION

For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - PURPOSE SECTION

Sanitizer - for hands

WARNINGS SECTION

For external use only, flammable, keep away from heat or flame.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN3
1039339ethanol 0.8 ML/ML Topical SolutionSCD3
1039339ethanol 80 % Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74054-100-082022-01-28C16284748780-1d6a99b39-3ad1-a426-e053-dadaa90af4c2a3d16ce9-1e9e-876d-e053-2a95a90af7b7
74054-100-092022-01-28C16284748780-1d6a99b39-3ad1-a426-e053-dadaa90af4c2a3d16ce9-1e9e-876d-e053-2a95a90af7b7
74054-100-102022-01-28C16284748780-1d6a99b39-3ad1-a426-e053-dadaa90af4c2a3d16ce9-1e9e-876d-e053-2a95a90af7b7
74054-100-112022-01-28C16284748780-1d6a99b39-3ad1-a426-e053-dadaa90af4c2a3d16ce9-1e9e-876d-e053-2a95a90af7b7
74054-100-122022-01-28C16284748780-1d6a99b39-3ad1-a426-e053-dadaa90af4c2a3d16ce9-1e9e-876d-e053-2a95a90af7b7
74054-100-132022-01-28C16284748780-1d6a99b39-3ad1-a426-e053-dadaa90af4c2a3d16ce9-1e9e-876d-e053-2a95a90af7b7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74054-100-08Hand Santizer2018198 mL in 1 DRUMLIQUID20181983
74054-100-09Hand Santizer189271 mL in 1 DRUMLIQUID1892713
74054-100-10Hand Santizer1893 mL in 1 BOTTLE, PLASTICLIQUID18933
74054-100-11Hand Santizer250 mL in 1 BOTTLE, PLASTICLIQUID2503
74054-100-12Hand Santizer750 mL in 1 BOTTLE, PLASTICLIQUID7503
74054-100-13Hand Santizer591 mL in 1 BOTTLE, PLASTICLIQUID5913

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74054-100HAND SANTIZER (ALCOHOL) LIQUID [ROBERT MAZZA, INC DBA FIVE & 20 SPIRITS]3Legacy NDC, 6 package rows20200422_a3d16ce9-1e9e-876d-e053-2a95a90af7b7.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
74054-10074054-100-08, 74054-100-09, 74054-100-10, 74054-100-11, 74054-100-12, 74054-100-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
a3d16c5e-5dac-7f57-e053-2a95a90a9a6fa3d16ce9-1e9e-876d-e053-2a95a90af7b72020-04-21WarningsExact identifier
spl id: a3d16c5e-5dac-7f57-e053-2a95a90a9a6f
spl set id: a3d16ce9-1e9e-876d-e053-2a95a90af7b7

Reported adverse events (FAERS/openFDA)#

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