FDA.reportPublic FDA data

OPTIMAL Hand Sanitizer

Manufacturer
Optisource International Inc.
Effective date
2022-12-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:43:03

Label at a glance#

ProductOPTIMAL Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium Chloride 0.1%

OTC - PURPOSE SECTION

Purpose

Antimicrobial

INDICATIONS & USAGE SECTION

Uses • For hand sanitizing to decrease bacteria on the skin • Recommended for repeat use

WARNINGS SECTION

Warnings
For external use only

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

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hrs.

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.

DOSAGE & ADMINISTRATION SECTION

Directions • Pump a small amount of foam into palm of hand • Rub thoroughly over all surfaces of both hands • Rub hands together briskly until dry.

INACTIVE INGREDIENT SECTION

Inactive ingredients Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2 cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

SPL UNCLASSIFIED SECTION

Alcohol-Free
Moisturizing

Kills 99.99% of Germs*

MADE IN USA

*of most common germs that may make you sick

Manufactured by: OptiSource International, Inc.

Bellport, NY 11713

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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
75447-20075447-200-50, 75447-200-02

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE0Y0NQR2GH1IACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
BEHENTRIMONIUM CHLORIDEX7GNG3S47TIACT
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT

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
8a45fd02-89db-41cf-a78f-ed0a12ce44454c20ee93-1729-45ef-b08f-583e48d4ab832024-07-17WarningsExact identifier
spl set id: 4c20ee93-1729-45ef-b08f-583e48d4ab83

Reported adverse events (FAERS/openFDA)#

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