FDA.reportPublic FDA data

Purmist

Manufacturer
MKR International Inc | McKenna Labs Inc
Effective date
2022-04-07
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:49:46

Label at a glance#

ProductPurmist
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Indications and uses

Leave on hand sanitizer to decrease harmful bacteria on the skin.

Dosage and administration

Spray as neeeded Rub hands together covering all areas, including fingernail areas thoroughly

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Cl 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Leave on hand sanitizer to decrease harmful bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

DO NOT USE

OTC - DO NOT USE SECTION

in or near eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

redness or irritation develop or persist for more than 72 hours.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

unless under adult supervision. If swallowed get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

  • Spray as neeeded
  • Rub hands together covering all areas, including fingernail areas thoroughly

Other Information

OTHER SAFETY INFORMATION

store at 2ºC to 40ºC (35.6ºF to 104ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

polysorbate 80, proprietary blend of natural botanical oils, water

Indications and Usage

RECENT MAJOR CHANGES SECTION

Leave on hand sanitizer to decrease harmful bacteria on the skin.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

300+ Sprays

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PURMIST 60 mL - 2.0 fl.oz.PURMIST 60 mL - 2.0 fl.oz.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN7
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD7
1049254benzalkonium chloride 0.13 % Topical SolutionSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50353-105-502024-01-30C16284748780-11030e365-59d5-111a-e063-dadaa90a10e2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50353-105-50Purmist60 mL in 1 BOTTLE, SPRAYLIQUID607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50353-105PURMIST (BENZALKONIUM CL) LIQUID [MKR INTERNATIONAL INC]7Legacy NDC, 1 package rows20220601_dbd86ed2-3bcc-67cd-e053-2995a90a9697.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
50353-10550353-105-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
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
e0546876-966a-a2de-e053-2995a90ad17bdbd86ed2-3bcc-67cd-e053-2995a90a96972022-04-07WarningsExact identifier
spl id: e0546876-966a-a2de-e053-2995a90ad17b
spl set id: dbd86ed2-3bcc-67cd-e053-2995a90a9697

Reported adverse events (FAERS/openFDA)#

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