FDA.reportPublic FDA data

Iso-Quin hand sanitizer

Manufacturer
The Hygenic Company, LLC.
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:08

Label at a glance#

ProductIso-Quin hand sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Helps decrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

Apply a small amount onto hands and rub briskly until dry. Do not rinse. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol Denat 65% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

Helps decrease bacteria on the skin. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

Flammable - keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

Use in a well-ventilated area. Do not use in or near eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor. In case of eye contact, flush eyes with water and consult a physician.

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

Apply a small amount onto hands and rub briskly until dry. Do not rinse. Children under 6 years of age should be supervised when using this product.

Other Information:

SPL UNCLASSIFIED SECTION

Store in a cool dry place with lid closed tightly

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, Fragrance, Yellow #11

Questions?

OTC - QUESTIONS SECTION

+1800 345-2231

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
884783ethanol 65 % Topical SolutionPSN2
884783ethanol 0.65 ML/ML Topical SolutionSCD2
884783ethanol 65 % Topical SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82345-858-10Iso-Quin hand sanitizer3785 mL in 1 BOTTLELIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82345-858ISO-QUIN HAND SANITIZER (ALCOHOL) LIQUID [THE HYGENIC COMPANY, LLC.]2Current NDC, Legacy NDC, 1 package rows20231106_d1003c9f-a6f8-3de2-e053-2995a90a6e8a.zip

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
82345-85882345-858-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
D&C YELLOW NO. 1144F3HYL954IACT
ALCOHOL3K9958V90MACTIB

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
Iso-Quin hand sanitizerALCOHOLThe Hygenic Company, LLC.d1003c9f-a6f8-3de2-e053-2995a90a6e8a2023-11-05WarningsExact identifier
ndc (package): 82345-858-10
ndc (product): 82345-858
ndc11 (package): 82345085810
spl id: 097353b6-422b-cea1-e063-6294a90aea19
spl set id: d1003c9f-a6f8-3de2-e053-2995a90a6e8a

Reported adverse events (FAERS/openFDA)#

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