FDA.reportPublic FDA data

Hand Armor

Manufacturer
HyGenesis | Elba, Inc.
Effective date
2021-10-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:44:18

Label at a glance#

ProductHand Armor
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

For hand sanitizing to decrease bacteria.

Dosage and administration

Wash hands Rub in 2 to 4 drops For Healthcare, repeat process every 4 hours

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

For hand sanitizing to decrease bacteria.

Warnings

WARNINGS SECTION

For external use only.

When using this product avoid contact with eyes.

OTC - WHEN USING SECTION

In case of contact, flush eyes with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation develops or if condition persists for more than 72 hours.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash hands
  • Rub in 2 to 4 drops
  • For Healthcare, repeat process every 4 hours

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Dimethicone Crosspolymer, Octadecyldimethyl Trimethoxysilylproply Ammonium Chloride, PPG-3 Benzyl Ether Ethylhexanoate

Questions or commetns?

OTC - QUESTIONS SECTION

248-342-8040

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN6
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD6
1049254benzalkonium chloride 0.13 % Topical SolutionSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58590-001-012023-01-30C16284748780-19d75b9cf-e66f-f424-e053-dadaa90a57cef9dc5264-3fe7-47de-a2c2-3debade8448a
58590-001-022023-01-30C16284748780-19d75b9cf-e66f-f424-e053-dadaa90a57cef9dc5264-3fe7-47de-a2c2-3debade8448a
58590-001-032023-01-30C16284748780-19d75b9cf-e66f-f424-e053-dadaa90a57cef9dc5264-3fe7-47de-a2c2-3debade8448a
58590-001-012020-04-03C16284748780-19d75b9cf-e66f-f424-e053-dadaa90a57cef9dc5264-3fe7-47de-a2c2-3debade8448a
58590-001-022020-04-03C16284748780-19d75b9cf-e66f-f424-e053-dadaa90a57cef9dc5264-3fe7-47de-a2c2-3debade8448a
58590-001-032020-04-03C16284748780-19d75b9cf-e66f-f424-e053-dadaa90a57cef9dc5264-3fe7-47de-a2c2-3debade8448a
58590-001-012020-01-31C16284748780-19d75b9cf-e66f-f424-e053-dadaa90a57cef9dc5264-3fe7-47de-a2c2-3debade8448a
58590-001-022020-01-31C16284748780-19d75b9cf-e66f-f424-e053-dadaa90a57cef9dc5264-3fe7-47de-a2c2-3debade8448a
58590-001-032020-01-31C16284748780-19d75b9cf-e66f-f424-e053-dadaa90a57cef9dc5264-3fe7-47de-a2c2-3debade8448a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58590-001-01Hand Armor21.26 g in 1 BOTTLELIQUID21.266
58590-001-02Hand Armor85.05 g in 1 BOTTLELIQUID85.056
58590-001-03Hand Armor170.1 g in 1 BOTTLELIQUID170.16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58590-001HAND ARMOR (BENZALKONIUM CHLORIDE) LIQUID [HYGENESIS]6Legacy NDC, 3 package rows20211016_f9dc5264-3fe7-47de-a2c2-3debade8448a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W73
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y3
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R3
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDEINACTIVE INGREDIENTIQ36O85WQ43
PPG-3 BENZYL ETHER ETHYLHEXANOATEINACTIVE INGREDIENT3N703GY99W3

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
58590-00158590-001-01, 58590-001-02, 58590-001-03

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
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDEIQ36O85WQ4IACT
PPG-3 BENZYL ETHER ETHYLHEXANOATE3N703GY99WIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates

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
ce6a21ba-4e62-e08e-e053-2a95a90a46bef9dc5264-3fe7-47de-a2c2-3debade8448a2021-10-15WarningsExact identifier
spl id: ce6a21ba-4e62-e08e-e053-2a95a90a46be
spl set id: f9dc5264-3fe7-47de-a2c2-3debade8448a

Reported adverse events (FAERS/openFDA)#

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