FDA.reportPublic FDA data

Hygieni-Klean Hand Sanitizer

Manufacturer
Custom Chemical Services, LLC
Effective date
2020-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:27:24

Label at a glance#

ProductHygieni-Klean Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure10 sections

Dosage and administration

Place hand sanitizer in your palm, thoroughly cover hands, including between fingers, under fingernails, and around wrists. Rub briskly until dry. No rinsing required.

Storage and handling

Store under 105°F. Avoid freezing and excessive heat above 104°F.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70% v/v 

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use(s)

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush eyes with water immediately.
Avoid contact with broken skin. Discontinue use if irritation or redness develops. If condition persists, consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Children should only use this product under adult supervison. Do not drink. Not edible. In case of accidential ingestion, seek professional assistance or contact a Poison Control Center immediately.

Other Information

STORAGE AND HANDLING SECTION

Store under 105°F. Avoid freezing and excessive heat above 104°F.

Directions

DOSAGE & ADMINISTRATION SECTION

Place hand sanitizer in your palm, thoroughly cover hands, including between fingers, under fingernails, and around wrists. Rub briskly until dry. No rinsing required.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Glycerin USP, PEG-600

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

SPL UNCLASSIFIED SECTION

PACKAGED & DISTRIBUTED BY

Custom Chemical Services, LLC

8230 FM 2004

Hitchcock, TX 77563

(409) 925-7818

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
78174-00378174-003-01

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
ISOPROPYL ALCOHOLND2M416302ACTIB
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
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
31896ecc-0f47-4fd4-92c7-dd2633e078fb449a1f6f-fac3-4106-a003-e48aba9f1a3d2021-04-12WarningsExact identifier
spl set id: 449a1f6f-fac3-4106-a003-e48aba9f1a3d

Reported adverse events (FAERS/openFDA)#

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