FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
MedZone Products, LLC | Hubot Healthcare LLC
Effective date
2020-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:29

Label at a glance#

ProductHand Sanitizer
Active ingredientAlcohol
Label structure11 sections

Indications and uses

for handwashing to decrease bacteria on the skin

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.

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62.5% v/v

Purposes

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

Do not use

OTC - DO NOT USE SECTION

In eyes | In children less than 2 months of age | On open skin wounds

When using this product

OTC - WHEN USING SECTION

If in eyes, rinse promptly and thoroughly with water | Discontinue use if irritation and redness develops

Stop use and ask a doctor

OTC - STOP USE SECTION

If irritation or rash occurs. These may be signs of a serious condition

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

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.

Other Information

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Propylene Glycol, Dimethicone Peg-7 Isostearate, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Aminomethylpropanediol, Tocopherol Acetate, Aloe Barbadensis Leaf Juice

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 Dr, Ste. 200,
Lenexa, Kansas 66215 USA

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MedZone®
SINCE 2001

Hand
Sanitizer

GEL

MADE IN USA

  • ANTISEPTIC HANDWASH
  • DAILY USE, TRAVEL,
    & SPORTS
  • RINSE FREE

OF COMMON ILLNESS CAUSING GERMS
KILLS
99.99%
IN 15 SECONDS

16 FL OZ (473mL)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1860080ethanol 62.5 % Topical GelPSN1
1860080ethanol 0.625 ML/ML Topical GelSCD1
1860080ethanol 62.5 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70338-604-162021-07-23C16284748780-1c7ccaba7-2187-fd44-e053-dadaa90aa01bHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70338-604-16Hand Sanitizer473 mL in 1 BOTTLE, PLASTICGEL4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70338-604HAND SANITIZER (ALCOHOL) GEL [MEDZONE PRODUCTS, LLC]1Legacy NDC, 1 package rows20200401_630f325f-e8a0-4de8-944e-bb048b0033a0.zip

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
70338-60470338-604-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MACTIB
Water059QF0KO0RIACT
Propylene Glycol6DC9Q167V3IACT
Dimethicone Peg-7 IsostearateJVS3399FNWIACT
Aminomethyl propanediolCZ7BU4QZJZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT

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
2ca74bc8-81cc-48be-8e7e-7c5488c2edb4630f325f-e8a0-4de8-944e-bb048b0033a02020-03-26WarningsExact identifier
spl id: 2ca74bc8-81cc-48be-8e7e-7c5488c2edb4
spl set id: 630f325f-e8a0-4de8-944e-bb048b0033a0

Reported adverse events (FAERS/openFDA)#

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