FDA.reportPublic FDA data

SpaSoap

Manufacturer
Sante Manufacturing Inc
Effective date
2017-03-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:49:14

Label at a glance#

ProductSpaSoap
Active ingredientALCOHOL
Label structure11 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 bacteria on the skin

WARNINGS SECTION

Warnings

Flammable

OTHER SAFETY INFORMATION

Keep away from fire or flame

INSTRUCTIONS FOR USE SECTION

For external use only

OTC - WHEN USING SECTION

When using this product do not use in or near eyes. In case of contact, rinse eyes thoroughly with water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply palmful to hands
    • rub hands together vigorously until dry
    • supervise children in the use of this product

INACTIVE INGREDIENT SECTION

Water, Carbomer, Trethanolamine, Glycerin, Propylene Glycol, Alo Barbdensis Leaf Juice*, Tocopherol Acetate*, Lavandula Angustifolia Flower / Leaf / Stem Extract*, Fragrance*, D&C Red # 33*, FD&C Blue # 1*, FD&C Yellow # 5*,

* Contains 1 or more of these ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spa Soap Hand SanitizerSpa Soap Hand Sanitizer​SpaSoap

Hand Sanitizer

2fl.oz (59ml) Each

6 fl.oz (177ml) Total

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN2
582753ethanol 0.7 ML/ML Topical SolutionSCD2
582753ethanol 70 % Topical SolutionSY2
582753ethyl alcohol 70 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71020-015-022020-01-31C16284748780-19d75b9d0-adb0-f424-e053-dadaa90a57ce4a70eac0-f696-3f8c-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71020-015-02SpaSoap177 mL in 1 PACKAGE, COMBINATIONLIQUID1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71020-015SPASOAP (HAND SANITIZER) LIQUID [SANTE MANUFACTURING INC]2Legacy NDC, 1 package rows20170311_4a70eac0-f696-3f8c-e054-00144ff8d46c.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
71020-01571020-015-02

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
FD&C YELLOW NO. 5I753WB2F1MIACT
LAVANDULA ANGUSTIFOLIA WHOLE51217XIL5LIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
4a77f5e6-7269-0cdb-e054-00144ff8d46c4a70eac0-f696-3f8c-e054-00144ff8d46c2017-03-11WarningsExact identifier
spl id: 4a77f5e6-7269-0cdb-e054-00144ff8d46c
spl set id: 4a70eac0-f696-3f8c-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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