FDA.reportPublic FDA data

SIREtizer Hand Sanitizer

Manufacturer
South Tenth Development, LLC
Effective date
2020-06-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:17:52

Label at a glance#

ProductSIREtizer Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

-Rcducebacteria on the skin -Recommended for repeted use

Dosage and administration

- Place enough to cover both hands in the palm, and rub hands together until dry. - Children under 6 years of age should be supervised by an adult when applying this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

-Rcducebacteria on the skin
-Recommended for repeted use

Warnings

WARNINGS SECTION

For external use only.

Flammable Keep away from fire, flame, or sparks

When using this product

OTC - WHEN USING SECTION

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

Stop use & ask a doctor

OTC - STOP USE SECTION

If irritation or rash appears on the skin.

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

- Place enough to cover both hands in the palm, and rub hands together until dry.
- Children under 6 years of age should be supervised by an adult when applying this product.

Other Information

SPL UNCLASSIFIED SECTION

- Store below 105°F.
- May discolor certain fabrics or surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Distilled water, glycerol, hydrogen peroxide, denatonium benzoate.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78705-002-002022-01-28C16284748780-1d6a99b39-748a-a426-e053-dadaa90af4c2SIREtizer Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78705-002-00SIREtizer Hand Sanitizer500 mL in 1 BOTTLELIQUID5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78705-002SIRETIZER HAND SANITIZER (ALCOHOL) LIQUID [SOUTH TENTH DEVELOPMENT, LLC]2Legacy NDC, 1 package rows20200616_f21eb274-6673-419c-94ca-eb7d43335df5.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78705-00278705-002-00

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
ALCOHOL3K9958V90MACTIB

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
a820ed99-9438-629f-e053-2995a90a1f6ff21eb274-6673-419c-94ca-eb7d43335df52020-06-15WarningsExact identifier
spl id: a820ed99-9438-629f-e053-2995a90a1f6f
spl set id: f21eb274-6673-419c-94ca-eb7d43335df5

Reported adverse events (FAERS/openFDA)#

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