FDA.reportPublic FDA data

Nimbus

Manufacturer
Nimbus Eco Inc. | American Hygienics Corporation
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:51

Label at a glance#

ProductNimbus
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

Open resealable label. Remove one wipe to use. Wipe hands thoroughly with product and allow to dry without wiping. Close resealable label after use to retain moisture.

Storage and handling

Dispose of wipe in the proper container Do not flush down the toilet Kill claims against: Escherichia Coli and Staphylococcus aureus

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizing wipe manufactured using only the following United States Pharmacopoeia (USP) grade ingredients

  1. Benzalkonium Chloride (USP grade) (0.12%, volume/volume (v/v))
  2. Water
    c. Propylene Glycol
    d. Ethyl Alcohol
    e. Lauryl Glucoside
    f. Phenoxyethanol
    g. Tetrasodium EDTA
    h. 3-Iodo-2-Propynyl ButylCarbamate
    i. 2-Bromo-2-Nitropropane-1,3-Diol
    j. Citric Acid
    k. Fragrance
    l. Aloe Barbadensis Leaf Extract
    m. Chamomilla Recutita Flower Extract

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1% Purpose: Antibacterial

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

Decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use if irritation and redness develop

OTC - WHEN USING SECTION

When using this product avoid contact with eyes, if contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition persists for more than 72 hours.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Open resealable label. Remove one wipe to use. Wipe hands thoroughly with product and allow to dry without wiping.

Close resealable label after use to retain moisture.

Other information

STORAGE AND HANDLING SECTION

Dispose of wipe in the proper container

Do not flush down the toilet

Kill claims against: Escherichia Coli and Staphylococcus aureus

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water
Propylene Glycol
Ethyl Alcohol
Lauryl Glucoside
Phenoxyethanol
Benzalkonium Chloride
Tetrasodium EDTA
3-Iodo-2-Propynyl ButylCarbamate
2-Bromo-2-Nitropropane-1,3-Diol
Citric Acid
Fragrance N/A
Aloe Barbadensis Leaf Extract
Chamomilla Recutita Flower Extract

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 count NDC: 81240-001-50

50 count50 count

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81240-001-502023-07-28C16284748780-10191ceaa-64cc-198a-e063-dbdaa90aec3eb6c5522f-209d-6865-e053-2995a90ac8d8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81240-001-50Nimbus30 mL in 1 PACKAGECLOTH302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81240-001NIMBUS (BENZALKONIUM CHLORIDE) CLOTH [NIMBUS ECO INC.]2Legacy NDC, 1 package rows20220114_b6c5522f-209d-6865-e053-2995a90ac8d8.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81240-00181240-001-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHAMOMILE FLOWER OIL60F80Z61A9IACT
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
BRONOPOL6PU1E16C9WIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
CHAMOMILEFGL3685T2XIACT

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
d57cc326-d853-0598-e053-2995a90acd95b6c5522f-209d-6865-e053-2995a90ac8d82022-01-13WarningsExact identifier
spl id: d57cc326-d853-0598-e053-2995a90acd95
spl set id: b6c5522f-209d-6865-e053-2995a90ac8d8

Reported adverse events (FAERS/openFDA)#

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