FDA.reportPublic FDA data

Unscented

Manufacturer
Sante Maufacturing Inc | Sante Manufacturing Inc
Effective date
2017-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:14

Label at a glance#

ProductUnscented
Active ingredientALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients - Ethyl Alcohol 70%

OTC - PURPOSE SECTION

Purpose - Antiseptic

INDICATIONS & USAGE SECTION

Use hand sanitizer to help reduce disease causing bacteria on teh skin

WARNINGS SECTION

Flammable

OTHER SAFETY INFORMATION

keep Away from fire or flame

OTC - WHEN USING SECTION

For external use only -

USER SAFETY WARNINGS SECTION

Avoid contact with eyes in case of contact, rinse eyes thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowd, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply liberally to hands and rub thoroughly until dry
  • supervise children in the use of this product

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, tocopheryl acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spasoap

Hand Sanitizer

Unscented with moisturizers & vitamin E

2oz / 59ml

UnscentedUnscented

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN1
582753ethanol 0.7 ML/ML Topical SolutionSCD1
582753ethanol 70 % Topical SolutionSY1
582753ethyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71020-011-022020-01-31C16284748780-19d75b9d0-2821-f424-e053-dadaa90a57ce4a6ef6ff-d507-3d47-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71020-011-02Unscented59 mL in 1 BOTTLE, PLASTICLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71020-011UNSCENTED (HAND SANITIZER) LIQUID [SANTE MAUFACTURING INC]1Legacy NDC, 1 package rows20170311_4a6ef6ff-d507-3d47-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71020-01171020-011-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
4a6ef6ff-d508-3d47-e054-00144ff88e884a6ef6ff-d507-3d47-e054-00144ff88e882017-03-11WarningsExact identifier
spl id: 4a6ef6ff-d508-3d47-e054-00144ff88e88
spl set id: 4a6ef6ff-d507-3d47-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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