FDA.reportPublic FDA data

Hygieni-Klean Hand Sanitizer Gel Fresh

Manufacturer
Custom Chemical Services, LLC
Effective date
2021-04-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:48

Label at a glance#

ProductHygieni-Klean Hand Sanitizer Gel Fresh
Active ingredientISOPROPYL ALCOHOL
Label structure10 sections

Storage and handling

Other Information Store under 105°F. 

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Isopropanol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antibacterial

INDICATIONS & USAGE SECTION

Uses Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use.

WARNINGS SECTION

Warning Flammable. Keep away from fire or flame. For external use only.

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.

STORAGE AND HANDLING SECTION

Other Information Store under 105°F. 

DOSAGE & ADMINISTRATION SECTION

Directions 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 INGREDIENT SECTION

Inactive Ingredients Purified water, Glycerin USP, PEG-600, Carbomer, Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01-1 gal: 

image descriptionimage description

02-32 oz:

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03-16 oz:

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04-12 oz:

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05-8 oz:

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06-4 oz:

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07-2 oz:

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2285607isopropyl alcohol 75 % Topical GelPSN1
2285607isopropyl alcohol 0.75 ML/ML Topical GelSCD1
2285607isopropyl alcohol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78174-020-012023-01-30C16284748780-1f386c64a-0b1f-0266-e053-dadaa90a7c1a9dfd99a0-de5c-4462-b2e3-8301037f658d
78174-020-022023-01-30C16284748780-1f386c64a-0b1f-0266-e053-dadaa90a7c1a9dfd99a0-de5c-4462-b2e3-8301037f658d
78174-020-032023-01-30C16284748780-1f386c64a-0b1f-0266-e053-dadaa90a7c1a9dfd99a0-de5c-4462-b2e3-8301037f658d
78174-020-042023-01-30C16284748780-1f386c64a-0b1f-0266-e053-dadaa90a7c1a9dfd99a0-de5c-4462-b2e3-8301037f658d
78174-020-052023-01-30C16284748780-1f386c64a-0b1f-0266-e053-dadaa90a7c1a9dfd99a0-de5c-4462-b2e3-8301037f658d
78174-020-062023-01-30C16284748780-1f386c64a-0b1f-0266-e053-dadaa90a7c1a9dfd99a0-de5c-4462-b2e3-8301037f658d
78174-020-072023-01-30C16284748780-1f386c64a-0b1f-0266-e053-dadaa90a7c1a9dfd99a0-de5c-4462-b2e3-8301037f658d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78174-020-01Hygieni-Klean Hand Sanitizer Gel Fresh3.78541 L in 1 JUGGEL3.785411
78174-020-02Hygieni-Klean Hand Sanitizer Gel Fresh0.946353 L in 1 BOTTLEGEL0.9463531
78174-020-03Hygieni-Klean Hand Sanitizer Gel Fresh0.473176 L in 1 BOTTLEGEL0.4731761
78174-020-04Hygieni-Klean Hand Sanitizer Gel Fresh0.354882 L in 1 BOTTLEGEL0.3548821
78174-020-05Hygieni-Klean Hand Sanitizer Gel Fresh0.236588 L in 1 BOTTLEGEL0.2365881
78174-020-06Hygieni-Klean Hand Sanitizer Gel Fresh0.118294 L in 1 BOTTLEGEL0.1182941
78174-020-07Hygieni-Klean Hand Sanitizer Gel Fresh0.0591471 L in 1 BOTTLEGEL0.05914711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78174-020HYGIENI-KLEAN HAND SANITIZER GEL FRESH (IPA) GEL [CUSTOM CHEMICAL SERVICES, LLC]1Legacy NDC, 7 package rows20210421_9dfd99a0-de5c-4462-b2e3-8301037f658d.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
78174-02078174-020-01, 78174-020-02, 78174-020-03, 78174-020-04, 78174-020-05, 78174-020-06, 78174-020-07

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
ISOPROPYL ALCOHOLND2M416302ACTIB
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S)F01RIY4371IACT
water059QF0KO0RIACT
FRAGRANCE CUCUMBER ALOE ORC1802955FSS3TH6V9MIACT

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
addf0229-9343-4e42-aef0-99df852146269dfd99a0-de5c-4462-b2e3-8301037f658d2021-04-20WarningsExact identifier
spl id: addf0229-9343-4e42-aef0-99df85214626
spl set id: 9dfd99a0-de5c-4462-b2e3-8301037f658d

Reported adverse events (FAERS/openFDA)#

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