FDA.reportPublic FDA data

PUREASE ANTISEPTIC HAND SANITIZER Gel

Manufacturer
PL COSMETIC
Effective date
2020-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:11:07

Label at a glance#

ProductPUREASE ANTISEPTIC HAND SANITIZER Gel
Active ingredientALCOHOL
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PUREASE ANTISEPTIC HAND SANITIZER GelPUREASE ANTISEPTIC HAND SANITIZER Gel

OTC - ACTIVE INGREDIENT SECTION

DOSAGE & ADMINISTRATION SECTION

OTC - PURPOSE SECTION

INDICATIONS & USAGE SECTION

INACTIVE INGREDIENT SECTION

OTC - DO NOT USE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - WHEN USING SECTION

INSTRUCTIONS FOR USE SECTION

WARNINGS SECTION

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74339-1007-22024-01-30C16284748780-11030e365-0d73-111a-e063-dadaa90a10e2PUREASE ANTISEPTIC HAND SANITIZER Gel 100 ml tube < outerbox: 74339-1007-2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74339-1007-2PUREASE ANTISEPTIC HAND SANITIZER Gel1 in 1 BOXGEL11
74339-1007-2PUREASE ANTISEPTIC HAND SANITIZER Gel100 mL in 1 TUBEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74339-1007PUREASE ANTISEPTIC HAND SANITIZER GEL (ETHYL ALCOHOL) GEL [PL COSMETIC]1Legacy NDC, 2 package rows20200513_a57ceb37-d731-de8f-e053-2995a90a5403.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
74339-100774339-1007-2

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
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HYALURONATE SODIUMYSE9PPT4THIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
a57ceb44-19cb-df97-e053-2995a90a5433a57ceb37-d731-de8f-e053-2995a90a54032020-05-12Exact identifier
spl id: a57ceb44-19cb-df97-e053-2995a90a5433
spl set id: a57ceb37-d731-de8f-e053-2995a90a5403

Reported adverse events (FAERS/openFDA)#

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