BE CLEAN ANTISEPTIC HAND Gel

Manufacturer
Maria Nila Inc.
Effective date
2020-08-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:06

Label at a glance#

ProductBE CLEAN ANTISEPTIC HAND Gel
Active ingredientALCOHOL
Label structure9 sections

Storage and handling

OTHER INFORMATION: Store between 15-25C (59-77F). Avoid freezing and excessive heat.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 77% v/v

PURPOSE:

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

USES(S): Hand sanitizer to help reduce bacteria that potentially can cause disease.

WARNINGS SECTION

WARNINGS: For external use only. Flammable. Keep away from heat or flame. 

DO NOT USE: On children less than 2 months of age. On open skin wounds.

WHEN USING THIS PRODUCT: Keep out of eyes, ears, mouth, or open orifices. Rinse eyes thoroughly with water and contact a physician if needed. Avoid ingestion.

STOP USE AND ASK A DOCTOR: 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.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: 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 SECTION

OTHER INFORMATION: Store between 15-25C (59-77F). Avoid freezing and excessive heat.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Water (Aqua), Propylene Glycol, Glycerin, Isopropyl Myristate, Carbomer, Aminomethyl Propanol.

SPL UNCLASSIFIED SECTION

GEL MAINS ANTI-SEPTIQUE

ALCOHOL BASED 77%

100% VEGAN

CRUELTY FREE

HIGH SKIN COMPATIBILITY

CLIMATE COMPENSATED

Made in USA

Distributed by Maria Nila Inc. 900 Third Avenue, 29th Floor, New York, New York 10022

www.marianila.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1788839ethanol 77 % Topical GelPSN1
1788839ethanol 0.77 ML/ML Topical GelSCD1
1788839ethanol 77 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79972-003-102022-01-28C16284748780-1d6a99b39-c6cb-a426-e053-dadaa90af4c2MARIA NILA BE CLEAN ANTISEPTIC HAND GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79972-003-10BE CLEAN ANTISEPTIC HAND Gel300 mL in 1 BOTTLE, PLASTICGEL3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79972-003BE CLEAN ANTISEPTIC HAND GEL (ETHYL ALCOHOL) GEL [MARIA NILA INC.]1Legacy NDC, 1 package rows20200808_55ddd1a1-883f-4a6b-82b9-e121696317a7.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
79972-00379972-003-10

Ingredients#

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

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

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
9c7943e1-48f4-4f18-a865-fb5d64e3c64755ddd1a1-883f-4a6b-82b9-e121696317a72020-08-05WarningsExact identifier
spl id: 9c7943e1-48f4-4f18-a865-fb5d64e3c647
spl set id: 55ddd1a1-883f-4a6b-82b9-e121696317a7

Reported adverse events (FAERS/openFDA)#

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