Hygieni-Klean Hand Sanitizer Gel

Manufacturer: Custom Chemical Services, LLC
Effective date: 2021-01-03
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:36:23

Label at a glance#

ProductHygieni-Klean Hand Sanitizer Gel

Active ingredientALCOHOL

Label structure10 sections

Storage and handling

Other Information Store under 105°F.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethanol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antibacterial

INDICATIONS & USAGE SECTION

UsesHand 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1305100	ethanol 75 % Topical Gel	PSN	1
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	1
1305100	ethanol 75 % Topical Gel	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
78174-013-01	2023-01-30	C162847	48780-1	f386c649-ab5a-0266-e053-dadaa90a7c1a	5ba5f3cf-bbd5-4155-becc-797da558a640
78174-013-02	2023-01-30	C162847	48780-1	f386c649-ab5a-0266-e053-dadaa90a7c1a	5ba5f3cf-bbd5-4155-becc-797da558a640
78174-013-03	2023-01-30	C162847	48780-1	f386c649-ab5a-0266-e053-dadaa90a7c1a	5ba5f3cf-bbd5-4155-becc-797da558a640
78174-013-04	2023-01-30	C162847	48780-1	f386c649-ab5a-0266-e053-dadaa90a7c1a	5ba5f3cf-bbd5-4155-becc-797da558a640
78174-013-05	2023-01-30	C162847	48780-1	f386c649-ab5a-0266-e053-dadaa90a7c1a	5ba5f3cf-bbd5-4155-becc-797da558a640
78174-013-06	2023-01-30	C162847	48780-1	f386c649-ab5a-0266-e053-dadaa90a7c1a	5ba5f3cf-bbd5-4155-becc-797da558a640
78174-013-07	2023-01-30	C162847	48780-1	f386c649-ab5a-0266-e053-dadaa90a7c1a	5ba5f3cf-bbd5-4155-becc-797da558a640

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78174-013-01	Hygieni-Klean Hand Sanitizer Gel	3.78541 L in 1 JUG	GEL	3.78541	1
78174-013-02	Hygieni-Klean Hand Sanitizer Gel	0.946353 L in 1 BOTTLE	GEL	0.946353	1
78174-013-03	Hygieni-Klean Hand Sanitizer Gel	0.473176 L in 1 BOTTLE	GEL	0.473176	1
78174-013-04	Hygieni-Klean Hand Sanitizer Gel	0.354882 L in 1 BOTTLE	GEL	0.354882	1
78174-013-05	Hygieni-Klean Hand Sanitizer Gel	0.236588 L in 1 BOTTLE	GEL	0.236588	1
78174-013-06	Hygieni-Klean Hand Sanitizer Gel	0.118294 L in 1 BOTTLE	GEL	0.118294	1
78174-013-07	Hygieni-Klean Hand Sanitizer Gel	0.0591471 L in 1 BOTTLE	GEL	0.0591471	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78174-013	HYGIENI-KLEAN HAND SANITIZER GEL (ALCOHOL) GEL [CUSTOM CHEMICAL SERVICES, LLC]	1	Legacy NDC, 7 package rows	20210104_5ba5f3cf-bbd5-4155-becc-797da558a640.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Hygieni-Klean Hand Sanitizer Gel
Alcohol
GLYCERIN
POLYETHYLENE GLYCOL 600
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S)
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
78174-013	78174-013-01, 78174-013-02, 78174-013-03, 78174-013-04, 78174-013-05, 78174-013-06, 78174-013-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	ACTIB
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 600	NL4J9F21N9	IACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S)	F01RIY4371	IACT
water	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f067ad5c-d08f-442e-bb6d-d5ce547a7905			5ba5f3cf-bbd5-4155-becc-797da558a640	2021-01-03	Warnings	Exact identifier spl id: f067ad5c-d08f-442e-bb6d-d5ce547a7905 spl set id: 5ba5f3cf-bbd5-4155-becc-797da558a640

Reported adverse events (FAERS/openFDA)#

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