FDA.reportPublic FDA data

Because

Manufacturer
PORTOFINO LABS, INC | Zhejiang Qimei Commodity Co.,Ltd
Effective date
2021-11-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:37

Label at a glance#

ProductBecause
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

for hand sanitizing to decrease bacteria on skin safe for repeated use

Dosage and administration

peel back label remove and unfold wipe wipe hands thoroughly for approximately 30 seconds dispose of in trash do not flush

Label contents#

Full prescribing information#

Active lngredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • for hand sanitizing to decrease bacteria on skin
  • safe for repeated use

Warnings

WARNINGS SECTION

For external use only

When using this product avoid contact with eyes

Stop use and ask a doctor If
•irritation or redness develop
•if conditions 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 the Poision Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • peel back label
  • remove and unfold wipe
  • wipe hands thoroughly for approximately 30 seconds
  • dispose of in trash
  • do not flush

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis Leaf Juice, Decyl Glucoside, Glycerin, Water

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN3
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD3
1038558benzalkonium chloride 0.13 % Topical ClothSY3
1038558benzalkonium chloride 0.13 % Topical SwabSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY3
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74088-001-012023-01-30C16284748780-1f386c649-d24c-0266-e053-dadaa90a7c1aBenzalkonium chloride impregnated moist hand wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74088-001-01Because20 in 1 POUCHCLOTH203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74088-001BECAUSE (BENZALKONIUM CHLORIDE) CLOTH [PORTOFINO LABS, INC]3Legacy NDC, 1 package rows20211102_8d3a6034-5f5c-441c-8a11-7e2ba010806a.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74088-00174088-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
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
cfbabe61-a7a8-5385-e053-2995a90aa9c08d3a6034-5f5c-441c-8a11-7e2ba010806a2021-11-01WarningsExact identifier
spl id: cfbabe61-a7a8-5385-e053-2995a90aa9c0
spl set id: 8d3a6034-5f5c-441c-8a11-7e2ba010806a

Reported adverse events (FAERS/openFDA)#

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