FDA.reportPublic FDA data

OPTISOURCE Antibacterial Foam Hand

Manufacturer
Charlotte Products Ltd.
Effective date
2019-12-04
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 23:01:44

Label at a glance#

ProductOPTISOURCE Antibacterial Foam Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Dosage and administration

Pump a small amount of foam into palm of hand Rub thoroughly over all surfaces of both hands for 15 seconds Rinse with potable water

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 washing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

When using

OTC - WHEN USING SECTION

this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop using and ask doctor if

OTC - STOP USE SECTION

irritation or redness 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Pump a small amount of foam into palm of hand
  • Rub thoroughly over all surfaces of both hands for 15 seconds
  • Rinse with potable water

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water/Agua/Eau, Coco-glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

12504 Label12504 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN10
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD10
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY10
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64646-001-022021-01-29C16284748780-1ba0f9c33-4905-a910-e053-dadaa90a0b8520fc9143-e675-18ae-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64646-001-02OPTISOURCE Antibacterial Foam Hand4 in 1 CASESOAP410
64646-001-02OPTISOURCE Antibacterial Foam Hand1250 mL in 1 BOTTLE, DISPENSINGSOAP125010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64646-001OPTISOURCE ANTIBACTERIAL FOAM HAND (BENZALKONIUM CHLORIDE) SOAP [CHARLOTTE PRODUCTS LTD.]10Legacy NDC, 2 package rows20191205_20fc9143-e675-18ae-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64646-00164646-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
COCO GLUCOSIDEICS790225BIACT

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
98dfe2f3-88e9-737e-e053-2a95a90ac37a20fc9143-e675-18ae-e054-00144ff8d46c2019-12-04WarningsExact identifier
spl id: 98dfe2f3-88e9-737e-e053-2a95a90ac37a
spl set id: 20fc9143-e675-18ae-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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