FDA.reportPublic FDA data

Foaming Hand Sanitizer

Manufacturer
MedZone Products, LLC | Hubot Healthcare LLC
Effective date
2020-05-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:15

Label at a glance#

ProductFoaming Hand Sanitizer
Active ingredientAlcohol
Label structure11 sections

Indications and uses

for handwashing to decrease bacteria on the skin

Dosage and administration

Spread thoroughly onto hands and rub until dry.

Storage and handling

For additional information, see Safety Data Sheets (SDS) | For emergency medical information in USA and Canada, call 1-888-255-3924 | For emergency medical information worldwide, call 1-813-248-0573

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62.5% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic handwash

Uses

INDICATIONS & USAGE SECTION

for handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only | Flammable, keep away from fire or flame, heat, sparks, and sources of static discharge | Contents under pressure. Do not store at temperatures above 120°F (48°C), puncture or incinerate. | Operate only with spout pointing down.

Do not use

OTC - DO NOT USE SECTION

In eyes

When using this product

OTC - WHEN USING SECTION

If in eyes, rinse promptly and thoroughly with water | Discontinue use if irritation and redness develop, stop use and ask a doctor if skin irritation or redness occur for 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Spread thoroughly onto hands and rub until dry.

Other

STORAGE AND HANDLING SECTION

For additional information, see Safety Data Sheets (SDS) | For emergency medical information in USA and Canada, call 1-888-255-3924 | For emergency medical information worldwide, call 1-813-248-0573

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Hydrofluorocarbon 152A, Isobutane, Emulsifying Wax, Steareth-20, Sodium Benzoate, Propane, Cetyl Lactate, Sodium Sesquicarbonate

Questions?

OTC - QUESTIONS SECTION

Toll Free 866-MEDZONE (866-633-9663) www.medzonecorp.com | info@medzonecorp.com

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
MedZone Products LLC
9300 Marshall Drive, Ste. 200
Lenexa, Kansas 66215

PRINCIPAL DISPLAY PANEL - 44 mL Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MedZone®
SINCE 2001

Foaming
Hand
Sanitizer

HOSPITAL STRENGTH

MADE IN USA

  • SOFTENS SKIN &
    PREVENTS DRYNESS
  • HYPO ALLERGENIC
  • ANTISEPTIC HANDWASH
  • RINSE FREE

KILLS
99.99%
OF COMMON ILLNESS CAUSING GERMS
IN 15 SECONDS

1.5 FL OZ (44mL)

PRINCIPAL DISPLAY PANEL - 44 mL Can Label
PRINCIPAL DISPLAY PANEL - 44 mL Can Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039465ethanol 62.5 % Topical FoamPSN1
1039465ethanol 0.625 ML/ML Topical FoamSCD1
1039465ethanol 62.5 % Topical FoamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70338-602-702021-07-23C16284748780-1c7ccaba7-295b-fd44-e053-dadaa90aa01bFoaming Hand Sanitizer
70338-602-802021-07-23C16284748780-1c7ccaba7-295b-fd44-e053-dadaa90aa01bFoaming Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70338-602-70Foaming Hand Sanitizer44 mL in 1 CANAEROSOL, FOAM441
70338-602-80Foaming Hand Sanitizer236 mL in 1 CANAEROSOL, FOAM2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70338-602FOAMING HAND SANITIZER (ALCOHOL) AEROSOL, FOAM [MEDZONE PRODUCTS, LLC]1Legacy NDC, 2 package rows20200530_8a63ab18-5421-448a-a5dc-8c6f5ef9d6de.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70338-60270338-602-70, 70338-602-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MACTIB
Water059QF0KO0RIACT
1,1-DIFLUOROETHANE0B1U8K2ME0IACT
IsobutaneBXR49TP611IACT
Steareth-20L0Q8IK9E08IACT
Sodium BenzoateOJ245FE5EUIACT
PropaneT75W9911L6IACT
Cetyl LactateA7EVH2RK4OIACT
Sodium SesquicarbonateY1X815621JIACT

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
bcd79fb8-6ccb-40d8-aa13-1fc70969e8f18a63ab18-5421-448a-a5dc-8c6f5ef9d6de2020-05-27WarningsExact identifier
spl id: bcd79fb8-6ccb-40d8-aa13-1fc70969e8f1
spl set id: 8a63ab18-5421-448a-a5dc-8c6f5ef9d6de

Reported adverse events (FAERS/openFDA)#

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