FDA.reportPublic FDA data

Hand Protector

Manufacturer
Cytonix, LLC | Elaine Lanza
Effective date
2020-09-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:45

Label at a glance#

ProductHand Protector
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient. Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose: Antiseptic. Hand and skin sanitizer.

INDICATIONS & USAGE SECTION

USES: to reduce bacteria on the skin that could cause disease. Recommended for repreat use.

WARNINGS SECTION

WARNINGS:

For external use only.

Do not use in the eyes.

When using this product avoid content with eyes. In case of eye contact flush with water. Stop use and ask doctor if irritation and redness develope.

Keep out of reach of children.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - WHEN USING SECTION

Avoid contact with eyes. In case of contact flush with plenty of water.

OTC - STOP USE SECTION

Stop use and ask doctor if irritation or redness develop.

INACTIVE INGREDIENT SECTION

3-(trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride, Glycerin, Water

DOSAGE & ADMINISTRATION SECTION

Apply liberally to hands and gently rub until dry. Reapply after 4 hours.

OTC - QUESTIONS SECTION

Cytonix, LLC, Beltsville, MD

20705 USA 301-470-6267

www.cytonix.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand Protector Label 79291-654-01 473mL

Hand Protector Label 79291-654-01Hand Protector Label 79291-654-01

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79291-654-012023-01-30C16284748780-1f386c64a-395b-0266-e053-dadaa90a7c1aaf99a358-8118-1649-e053-2a95a90a20bf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79291-654-01Hand Protector473 mL in 1 BOTTLE, SPRAYSOLUTION4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79291-654HAND PROTECTOR (BENZALKONIUM CHLORIDE) SOLUTION [CYTONIX, LLC]1Legacy NDC, 1 package rows20200919_af99a358-8118-1649-e053-2a95a90a20bf.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
79291-65479291-654-01

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
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERINPDC6A3C0OXIACT
OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDEGLJ50K866TIACT

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
af99a358-8119-1649-e053-2a95a90a20bfaf99a358-8118-1649-e053-2a95a90a20bf2020-09-18WarningsExact identifier
spl id: af99a358-8119-1649-e053-2a95a90a20bf
spl set id: af99a358-8118-1649-e053-2a95a90a20bf

Reported adverse events (FAERS/openFDA)#

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