Hygenix AF Gel

Manufacturer: GM Industrial, Inc.
Effective date: 2021-10-05
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:44:17

Label at a glance#

ProductHygenix AF Gel

Active ingredientBENZALKONIUM CHLORIDE

Label structure2 sections

Boxed warning

Benzalkonium chloride 0.1% Antimicrobial For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use. For external use only When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or...

Label contents#

Full prescribing information#

Drug Facts

BOXED WARNING SECTION

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.1%

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops, or if condition persists 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 a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Pump a small amount of gel into pal of hand
Rub thoroughly over all surfaces of both hands
Rub hands together briskly until dry.

INACTIVE INGREDIENT SECTION

Water, carbomer, glycerin, lactic acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

74146-244-02 200 mL NDC: 74146-244-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049228	benzalkonium chloride 0.1 % Topical Gel	PSN	2
1049228	benzalkonium chloride 0.001 MG/MG Topical Gel	SCD	2
1049228	benzalkonium chloride 0.1 % Topical Gel	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
74146-244-03	2022-07-29	C162847	48780-1	e4f33bdf-9f1e-d8a0-e053-dadaa90a6e4e	b4697319-437e-2ec8-e053-2a95a90abb56

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
74146-244-02	Hygenix AF Gel	200 mL in 1 CONTAINER	GEL	200		2
74146-244-03	Hygenix AF Gel	24 in 1 BOX	GEL	24		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
74146-244	HYGENIX AF GEL (BENZALKONIUM CHLORIDE) GEL [GM INDUSTRIAL, INC.]	2	Legacy NDC, 2 package rows	20211016_b4697319-437e-2ec8-e053-2a95a90abb56.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Hygenix AF Gel
Benzalkonium chloride
LACTIC ACID
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
BENZALKONIUM
WATER
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
74146-244	74146-244-02, 74146-244-03

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
LACTIC ACID	33X04XA5AT	IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE	0A5MM307FC	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	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
b7165148-70d9-7ac2-e053-2995a90a365b			b4697319-437e-2ec8-e053-2a95a90abb56	2021-10-05	Boxed warning, Warnings	Exact identifier spl id: b7165148-70d9-7ac2-e053-2995a90a365b spl set id: b4697319-437e-2ec8-e053-2a95a90abb56

Reported adverse events (FAERS/openFDA)#

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