FDA.reportPublic FDA data

Hand Sanitizer with aloe vera

Manufacturer
MedZone Products, LLC | Pharmco Laboratories, Inc.
Effective date
2020-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:28:33

Label at a glance#

ProductHand Sanitizer with aloe vera
Active ingredientAlcohol
Label structure11 sections

Indications and uses

Hand sanitizer to help reduce bacteria on the skin

Dosage and administration

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry | Children under 6 years of age should be supervised when using this product.

Storage and handling

Store below 43˚C (110˚F) | May discolor certain fabrics or surfaces | For emergency medical information call 1-800-635-0712

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purposes

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce 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

On children less than 2 years of age | On open wounds

When using this product

OTC - WHEN USING SECTION

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with waters.

Discontinue use

OTC - STOP USE SECTION

If irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry | Children under 6 years of age should be supervised when using this product.

Other Information

STORAGE AND HANDLING SECTION

Store below 43˚C (110˚F) | May discolor certain fabrics or surfaces | For emergency medical information call 1-800-635-0712

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Citric Acid, Sodium Hydroxide

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 - 3.79 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MedZone®
SINCE 2001

Hand
Sanitizer

GEL

MADE IN USA

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

MADE WITH
MOISTURIZING ALOE VERA

128 FL OZ—1 GALLON (3.79L)

PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label
PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70338-610-282022-01-28C16284748780-1d6a99b39-7a8c-a426-e053-dadaa90af4c2Hand Sanitizer with aloe vera

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70338-610-28Hand Sanitizer with aloe vera3780 mL in 1 BOTTLEGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70338-610HAND SANITIZER WITH ALOE VERA (ALCOHOL) GEL [MEDZONE PRODUCTS, LLC]1Legacy NDC, 1 package rows20200907_2dc83791-332a-44bb-9dfa-8555de75937b.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
70338-61070338-610-28

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
GlycerinPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
Sodium Hydroxide55X04QC32IIACT

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
5e33f1f4-f0cd-454a-a2cd-eb13ff3b593b2dc83791-332a-44bb-9dfa-8555de75937b2020-08-24WarningsExact identifier
spl id: 5e33f1f4-f0cd-454a-a2cd-eb13ff3b593b
spl set id: 2dc83791-332a-44bb-9dfa-8555de75937b

Reported adverse events (FAERS/openFDA)#

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