FDA.reportPublic FDA data

Simoniz Hand Sanitizer Gel

Manufacturer
Simoniz, USA, Inc.
Effective date
2021-02-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:52:40

Label at a glance#

ProductSimoniz Hand Sanitizing
Active ingredientALCOHOL
Label structure10 sections

Storage and handling

Other Information May discolor certain fabrics and surfaces.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Ethyl Alcohol 70% v/v

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • To decrease bacteria on the skin that potentially can cause disease.
  • Recommended for repeated use.

WARNINGS SECTION

Warnings

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

OTC - WHEN USING SECTION

Keep out of eyes, ears or mouth. In case of eye contact, flush with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop or if condition persists more than 72 hours.

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. Children should be supervised by an adult when using this product.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply sufficient amount of product to your palm to cover both hands.
  • Rub until dry.

STORAGE AND HANDLING SECTION

Other Information May discolor certain fabrics and surfaces.

INACTIVE INGREDIENT SECTION

Inactive ingredients Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E, Water

SPL UNCLASSIFIED SECTION

Questions?

Call: 1-800-227-5536 or visit our website: www.simonizjanitorial.com

SIMONIZ

SIMONIZ USA, INC.

201 Boston Tpke.

Bolton, CT 06043

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIMONIZ

instant waterless

ALCOHOL HAND SANITIZING GEL

with Vitamin E

Dries quickly, leaves skin feeling soothed and moisturized

KILLS 99.99% OF GERMS

8 oz

C-PDPC-PDP

C - Drug FactsC - Drug Facts

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
63900-00463900-004-08

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
ALPHA-TOCOPHEROLH4N855PNZ1IACT
TROLAMINE9O3K93S3TKIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
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
f306c7f6-7599-366f-e053-2a95a90a4dd0bb3e2655-0fb8-a422-e053-2a95a90a99aa2023-01-24WarningsExact identifier
spl set id: bb3e2655-0fb8-a422-e053-2a95a90a99aa

Reported adverse events (FAERS/openFDA)#

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