FDA.reportPublic FDA data

HAND SANITIZER EARTHZEN

Manufacturer
PROBEMEX S.A. DE CV
Effective date
2020-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:36

Label at a glance#

ProductHAND SANITIZER EARTHZEN
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

PLACE ENOUGH PRODUCTO NO HANDS TO COVER ALL SUFACES. RUB HANDS TOGETHER UNTIL DRY. SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING OTHER INFORMATION: STORE BETWEEN 15-30C. AVOID FREEZING AND EXCESSIVE HEAT ABOCE 40C MAY DISCOLOR CERTAIN FABRIC OR SUFACES

Label contents#

Full prescribing information#

ACTIVE INGRIDIENT

OTC - ACTIVE INGREDIENT SECTION

ETHYL ALCOHOL 70%

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

STOP USE

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH APPEARS AND LAST. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

WARNING

WARNINGS AND PRECAUTIONS SECTION

WARNINGS: FLAMMABLE KEEP AWAY FROM HEAT OR FLAME. FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT DO NOT USE IN OR NEAR THE YES. IN CASE OF CONTACT RINSE EYE THRROUGHLY WITH WATER

DO NOT USE ON CHILDREN LESS THAN 2 MONTHS OF AGE. OPEN SKIN WOUNDS AVOID CONTACT WIITH BROKER SKIN

DIRECTIONS

INDICATIONS & USAGE SECTION

PLACE ENOUGH PRODUCTO NO HANDS TO COVER ALL SUFACES. RUB HANDS TOGETHER UNTIL DRY.

SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING

OTHER INFORMATION: STORE BETWEEN 15-30C. AVOID FREEZING AND EXCESSIVE HEAT ABOCE 40C

MAY DISCOLOR CERTAIN FABRIC OR SUFACES

INACTIVE

INACTIVE INGREDIENT SECTION

WATER, CARBOMER PROPANEDIOL AMINOMETHYL PROPANOL PEG 40 HYDROGENATED CASTOR OIL GLYCERIN

WARNING

WARNINGS SECTION

WARNING FLAMMABLE KEEP AWAY FROM HEAT

DOSAGE

DOSAGE & ADMINISTRATION SECTION

PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACE

KEEP OUT OF REACH

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

PACKAGE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EARTHEARTH42955-011-01

42955-011-02

42955-011-03

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
42955-011-012022-01-28C16284748780-1d6a99b39-adb0-a426-e053-dadaa90af4c2HAND SANITIZER EARTHZEN
42955-011-022022-01-28C16284748780-1d6a99b39-adb0-a426-e053-dadaa90af4c2HAND SANITIZER EARTHZEN
42955-011-032022-01-28C16284748780-1d6a99b39-adb0-a426-e053-dadaa90af4c2HAND SANITIZER EARTHZEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42955-011-01HAND SANITIZER EARTHZEN52 mL in 1 BOTTLEGEL521
42955-011-02HAND SANITIZER EARTHZEN250 mL in 1 BOTTLEGEL2501
42955-011-03HAND SANITIZER EARTHZEN1.5 mL in 1 DOSE PACKGEL1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42955-011HAND SANITIZER EARTHZEN (HAND SANIZITER EARTHZEN) GEL [PROBEMEX S.A. DE CV]1Legacy NDC, 3 package rows20200813_acb3e182-6031-06f1-e053-2995a90a161c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42955-01142955-011-01, 42955-011-03, 42955-011-02

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
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
WATER059QF0KO0RIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT

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
acb3e182-6032-06f1-e053-2995a90a161cacb3e182-6031-06f1-e053-2995a90a161c2020-08-12WarningsExact identifier
spl id: acb3e182-6032-06f1-e053-2995a90a161c
spl set id: acb3e182-6031-06f1-e053-2995a90a161c

Reported adverse events (FAERS/openFDA)#

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