FDA.reportPublic FDA data

Novex Hand Sanitizer

Manufacturer
Natural Essentials, Inc.
Effective date
2024-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:12

Label at a glance#

ProductNovex Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

Apply a small amount to palms, rub hands thoroughly until completely dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use in or near the eyes. In case of contact with eyes, flush thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask doctor if skin irritation develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a small amount to palms, rub hands thoroughly until completely dry.

Other Information

OTHER SAFETY INFORMATION

Do not freeze.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Cocamidopropyl Betaine.

Principal Display Panel – 225 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NOVEX

HAND
SANITIZER

ALCOHOL FREE

7.6 FL OZ (225 mL)

Principal Display Panel – 225 mL Bottle Label
Principal Display Panel – 225 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN1
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD1
1049254benzalkonium chloride 0.13 % Topical SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66902-037-25Novex Hand Sanitizer225 mL in 1 BOTTLELIQUID2251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-037NOVEX HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [NATURAL ESSENTIALS, INC.]1Current NDC, 1 package rows20240323_8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66902-03766902-037-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT

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
Novex Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.8b53dde5-c9f6-41c4-8ddb-bf0bf67008d32024-03-20WarningsExact identifier
ndc (package): 66902-037-25
ndc (product): 66902-037
ndc11 (package): 66902003725
spl id: a8d0a225-5348-4976-8bee-8d3fe79b3d12
spl set id: 8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3

Reported adverse events (FAERS/openFDA)#

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