FDA.reportPublic FDA data

Handzitizer

Manufacturer
SYNBIONIC EVOLUTION, INC.
Effective date
2020-11-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:33:21

Label at a glance#

ProductHandzitizer
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Directions:

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Warning

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or open flame.

Non medicinal ingredients

INACTIVE INGREDIENT SECTION

Purified water USP, Glycerin, Acrylic Acid Copolymer

Use

INDICATIONS & USAGE SECTION

To help reduce bacteria that potentially can cause disease. For when soap and water are not available.

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. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Alcohol, USP grade. 70% V/V

Handzitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Handzitizer - 4LHandzitizer - 4LHandzitizer - 1000LHandzitizer - 1000L

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79536-002-012022-01-28C16284748780-1d6a99b39-7f24-a426-e053-dadaa90af4c2Handzitizer
79536-002-022022-01-28C16284748780-1d6a99b39-7f24-a426-e053-dadaa90af4c2Handzitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79536-002-01Handzitizer4000 mL in 1 BOTTLE, PLASTICGEL40002
79536-002-02Handzitizer1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79536-002HANDZITIZER (GEL HAND SANITIZER) GEL [SYNBIONIC EVOLUTION, INC.]2Legacy NDC, 2 package rows20201111_b325fe2a-4388-18d9-e053-2995a90a9216.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
79536-00279536-002-01, 79536-002-02

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
CARBOMER 934Z135WT9208IACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
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
b3b17b19-f3a8-9c3d-e053-2995a90ae179b325fe2a-4388-18d9-e053-2995a90a92162020-11-09WarningsExact identifier
spl id: b3b17b19-f3a8-9c3d-e053-2995a90ae179
spl set id: b325fe2a-4388-18d9-e053-2995a90a9216

Reported adverse events (FAERS/openFDA)#

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