FDA.reportPublic FDA data

Foaming Alcohol Hand Sanitizer

Manufacturer
Simoniz USA, Inc
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:22

Label at a glance#

ProductFoaming Alcohol Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

If hands are visibily soiled, wash with soap and water and dry hands. Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

Label contents#

Full prescribing information#

​Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% (v/v)

​Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin after changing diapers, after assisting ill persons or before contact with a person under medical care or treatment. Recommended for repeated use.

Warnings

WARNINGS SECTION

  • For external use only. Keep out of eyes, ears or mouth.

OTC - STOP USE SECTION

  • Discontinue use if irritation occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children

FLAMMABLE.  KEEP AWAY FROM FIRE OR FLAME

Directions

DOSAGE & ADMINISTRATION SECTION

  • If hands are visibily soiled, wash with soap and water and dry hands.
  • Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing.

Other Information

SPL UNCLASSIFIED SECTION

  • Store between 59-86°F (15-30°C)
  • Avoid freezing and excessive heat above 104°F (40°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycereth-2-cocoate, DEA-C8-18 Perfluroalkylethyl Phosphate, water.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616763ethanol 62 % Topical FoamPSN4
616763ethanol 0.62 ML/ML Topical FoamSCD4
616763ethanol 62 % Topical FoamSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63900-002-00Foaming Alcohol Hand Sanitizer1000 mL in 1 BAGLIQUID10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63900-002FOAMING ALCOHOL HAND SANITIZER (ALCOHOL) LIQUID [SIMONIZ USA, INC]4Current NDC, Legacy NDC, 1 package rows20231030_d8925e9b-dd6e-4fad-aa3f-ae8fb895f2e1.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63900-00263900-002-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERETH-2 COCOATEJWM00VS7HCIACT
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE4J55VM509SIACT
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
Foaming Alcohol Hand SanitizerALCOHOLSimoniz USA, Incd8925e9b-dd6e-4fad-aa3f-ae8fb895f2e12023-10-28WarningsExact identifier
ndc (package): 63900-002-00
ndc (product): 63900-002
ndc11 (package): 63900000200
spl id: 08bfee10-3530-f20e-e063-6394a90a635b
spl set id: d8925e9b-dd6e-4fad-aa3f-ae8fb895f2e1

Reported adverse events (FAERS/openFDA)#

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