FDA.reportPublic FDA data

Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer

Manufacturer
Orbizorb LLC
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:02

Label at a glance#

ProductRough and Smooth Heavy Duty Antiseptic Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

Peel back the foil seal and pull the center wipe through the slot in the lid. Wet hands thoroughly with product and allow to dry without wiping. Close lid after use to prevent wipes from drying out.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • For hand washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop.
  • If condition persists for more than 72 hours consult a doctor.

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Peel back the foil seal and pull the center wipe through the slot in the lid.
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Close lid after use to prevent wipes from drying out.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Estasol, Poloxalene, PEG-75 Lanolin, Glycerin, Aloe Barbadensis Extract, Polyethylene glycol, Lauryl Glycosides, Fragrance, Disodium EDTA, 2-bromo-2-nitropropane-1,3-diol, 1,2-benzisothiazolin-3-one.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Updated 80ct LabelUpdated 80ct Label

Package Labeling:2wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:40wipes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN4
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD4
1038558benzalkonium chloride 0.13 % Topical ClothSY4
1038558benzalkonium chloride 0.13 % Topical SwabSY4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY4
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90119-001-022025-01-30C16284748780-12cef2736-7bdb-d83d-e063-dadaa90ab31fRough and Smooth Heavy Duty Antiseptic Hand Sanitizer
90119-001-402025-01-30C16284748780-12cef2736-7bdb-d83d-e063-dadaa90ab31fRough and Smooth Heavy Duty Antiseptic Hand Sanitizer
90119-001-802025-01-30C16284748780-12cef2736-7bdb-d83d-e063-dadaa90ab31fRough and Smooth Heavy Duty Antiseptic Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90119-001-02Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer2 in 1 PACKAGECLOTH24
90119-001-02Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer7.656 g in 1 PATCHCLOTH7.6564
90119-001-40Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer40 in 1 PACKAGECLOTH404
90119-001-40Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer7.656 g in 1 PATCHCLOTH7.6564
90119-001-80Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer612.48 g in 1 PATCHCLOTH612.484
90119-001-80Rough and Smooth Heavy Duty Antiseptic Hand Sanitizer80 in 1 CANISTERCLOTH804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90119-001ROUGH AND SMOOTH HEAVY DUTY ANTISEPTIC HAND SANITIZER (BENZALKONIUM CHLORIDE) CLOTH [ORBIZORB LLC]4Legacy NDC, 6 package rows20231027_ad67aa59-1fe5-0d75-e053-2995a90ac7e0.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
90119-00190119-001-80, 90119-001-02, 90119-001-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLOXALENEV8B3K56SW0IACT
PEG-75 LANOLIN09179OX7TBIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
BRONOPOL6PU1E16C9WIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
08aae52c-2d0c-377b-e063-6294a90a0635ad67aa59-1fe5-0d75-e053-2995a90ac7e02023-10-26WarningsExact identifier
spl id: 08aae52c-2d0c-377b-e063-6294a90a0635
spl set id: ad67aa59-1fe5-0d75-e053-2995a90ac7e0

Reported adverse events (FAERS/openFDA)#

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