FDA.reportPublic FDA data

Hand Sanitizer Solution 101

Manufacturer
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.
Effective date
2015-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:29:48

Label at a glance#

ProductHand Sanitizer Solution 101
Active ingredientBENZALKONIUM CHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

No-Rinse E3 Hand Sanitizer-Gentle on the hands-Contains IPA for a Rapid Kill-Anti-Bacterial-Quick Drying-USDA & Kosher Aprroved-Contains Bezalkonium Chloride for Extended Protection Hand Sanitizer Solution #101 helps to reduce the level of bacteria on the s...

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkoium Chloride.....0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

For Hand Sanitizing to decrease bacteria on the skin

Warnings:

WARNINGS SECTION

- For external use only

-Flammable keep away from fire or flame

​ ​When using this product

-Avoid contact with the eyes

In case of eye contact, flush eyes with water.

OTC - STOP USE SECTION

​Stop use and ask doctor if

--irritation or redness develops, if conditions persisit 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 poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

-Wash hands with soap and water Rinse with potable water- wet entire surface of hands with product especially the cuticles and fingernails -Rub hands together until dry - Do not rinse hands - Re-apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Isopropyl Alcohol, Water

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50241-246-012022-12-29C16284748780-19d75b9d0-803e-f424-e053-dadaa90a57ceHand Sanitizer Solution 101
50241-246-022022-12-29C16284748780-19d75b9d0-803e-f424-e053-dadaa90a57ceHand Sanitizer Solution 101
50241-246-012020-01-31C16284748780-19d75b9d0-803e-f424-e053-dadaa90a57ceHand Sanitizer Solution 101
50241-246-022020-01-31C16284748780-19d75b9d0-803e-f424-e053-dadaa90a57ceHand Sanitizer Solution 101

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50241-24650241-246-02, 50241-246-08, 50241-246-01

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT

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
ed9c2dd2-1764-4346-9d29-7d15831ca3570521e8bf-e157-403b-9e9b-6da89a51d6b82022-12-29WarningsExact identifier
spl set id: 0521e8bf-e157-403b-9e9b-6da89a51d6b8

Reported adverse events (FAERS/openFDA)#

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