FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Simoniz USA, Inc. | Best Sanitizers
Effective date
2018-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:02

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use

Dosage and administration

Dispense a small amount of gel into palm of hand Rub thoroughly over all surfaces of both hands Rub hands together until dry

Storage and handling

Store in a cool dry place below 104°F

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

  • For hand sanitizing to decrease bacteria on the skin.
  • Recommended for repeated use

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable, keep away from fire or flame

OTC - WHEN USING SECTION

When using this product

  • Do not use in or near eyes
  • Use in a well-ventilated area
  • Discontinue use if irritation and redness develop

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Dispense a small amount of gel into palm of hand
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together until dry

Other information

STORAGE AND HANDLING SECTION

  • Store in a cool dry place below 104°F

Inactive ingredients

INACTIVE INGREDIENT SECTION

DEA-C8-18 perfluoroalkylethyl phosphate, Glycereth-2 cocoate, Water, Denatoniom Benzoate, Tert-Butyl Alcohol

OTC - QUESTIONS SECTION

Questions?

Contact Simoniz Mon-Fri 8am-5pm EST at 1-800-227-5536

Bolton, CT 06043

SaniCheck

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER

Antiseptic Foam

Kills 99.999% of most Germs Without Water

Hospital Approved

250 mL - (8.45 fl oz)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sanicheck Foam FrontSanicheck Foam FrontSanicheck Foam BackSanicheck Foam Back

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63900-130-042020-01-31C16284748780-19d75b9d0-1ce7-f424-e053-dadaa90a57ceSaniCheck Hand Sanitizer

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63900-130HAND SANITIZER (ETHYL ALCOHOL) LIQUID [SIMONIZ USA, INC.]2Legacy NDC20190101_1eda55f3-612e-69ec-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M1
ALCOHOLACTIVE MOIETY3K9958V90M1
DENATONIUM BENZOATEINACTIVE INGREDIENT4YK5Z54AT21
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATEINACTIVE INGREDIENT4J55VM509S1
GLYCERETH-2 COCOATEINACTIVE INGREDIENTJWM00VS7HC1
TERT-BUTYL ALCOHOLINACTIVE INGREDIENTMD83SFE9591
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63900-13063900-130-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
ALCOHOL3K9958V90MACTIB
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE4J55VM509SIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DENATONIUM BENZOATEDENATONIUM BENZOATE4YK5Z54AT2SWAB / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
DENATONIUM BENZOATEDENATONIUM BENZOATE4YK5Z54AT2SOLUTION / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
DENATONIUM BENZOATEDENATONIUM BENZOATE4YK5Z54AT2GEL / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
TERT-BUTYL ALCOHOLTERT-BUTYL ALCOHOLMD83SFE959GEL / TOPICAL0.12 %w/wExact identifier — unii candidate

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
40d0794e-f75c-e677-e063-6394a90af5411eda55f3-612e-69ec-e054-00144ff8d46c2025-10-10WarningsExact identifier
spl set id: 1eda55f3-612e-69ec-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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