FDA.reportPublic FDA data

Instant Gel

Manufacturer
GM Industrial, Inc.
Effective date
2020-12-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:35:04

Label at a glance#

ProductInstant Gel
Active ingredientBENZALKONIUM CHLORIDE
Label structure15 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#

BOXED WARNING SECTION

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

OTC - PURPOSE SECTION

Antimicrobial

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.

DOSAGE & ADMINISTRATION SECTION

  • Pump a small amount of gel into palm 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

1 Gal 74146-239-01 1 GAL NDC: 74146-239-011 GAL NDC: 74146-239-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 GAL NDC: 74146-239-101 GAL NDC: 74146-239-101 Gal NDC 74146-239-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 74146-239-021000 mL NDC: 74146-239-021000 mL NDC 74146-239-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 74146-239-11 1000 mL NDC 74146-239-111000 mL NDC 74146-239-11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2.5 L NDC: 74146-239-032.5 L NDC: 74146-239-032.5 L NDC 74146-239-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2.5 L NDC: 74146-239-122.5 L NDC: 74146-239-122.5 L NDC 74146-239-12

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.55 L NDC: 74146-239-043.55 L NDC: 74146-239-043.55 L NDC: 74146-239-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.55 L NDC: 74146-239-133.55 L NDC: 74146-239-133.55 NDC 74146-239-13

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL NDC: 74146-239-05100 mL NDC: 74146-239-05100 mL NDC 74146-239-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL NDC: 74146-239-14100 mL NDC: 74146-239-14100 mL NDC 74146-239-14

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200 mL NDC: 74146-239-06200 mL NDC: 74146-239-06200 mL NDC 74146-239-06

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200 mL NDC: 74146-239-15200 mL NDC: 74146-239-15200 mL NDC 74146-239-15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 QT NDC: 74146-239-071 QT NDC: 74146-239-071 QT 74146-239-07

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 QT NDC: 74146-239-161 QT NDC: 74146-239-161 QT NDC 74146-239-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049228benzalkonium chloride 0.1 % Topical GelPSN4
1049228benzalkonium chloride 0.001 MG/MG Topical GelSCD4
1049228benzalkonium chloride 0.1 % Topical GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74146-239-102022-01-28C16284748780-1d6a99b3a-0069-a426-e053-dadaa90af4c2b326d984-287a-7f7d-e053-2995a90aaf13
74146-239-112022-01-28C16284748780-1d6a99b3a-0069-a426-e053-dadaa90af4c2b326d984-287a-7f7d-e053-2995a90aaf13
74146-239-122022-01-28C16284748780-1d6a99b3a-0069-a426-e053-dadaa90af4c2b326d984-287a-7f7d-e053-2995a90aaf13
74146-239-132022-01-28C16284748780-1d6a99b3a-0069-a426-e053-dadaa90af4c2b326d984-287a-7f7d-e053-2995a90aaf13
74146-239-142022-01-28C16284748780-1d6a99b3a-0069-a426-e053-dadaa90af4c2b326d984-287a-7f7d-e053-2995a90aaf13
74146-239-152022-01-28C16284748780-1d6a99b3a-0069-a426-e053-dadaa90af4c2b326d984-287a-7f7d-e053-2995a90aaf13
74146-239-162022-01-28C16284748780-1d6a99b3a-0069-a426-e053-dadaa90af4c2b326d984-287a-7f7d-e053-2995a90aaf13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74146-239-01Instant Gel3785.41 mL in 1 CONTAINERGEL3785.414
74146-239-02Instant Gel1000 mL in 1 JUGGEL10004
74146-239-03Instant Gel2500 mL in 1 JUGGEL25004
74146-239-04Instant Gel3550 mL in 1 JUGGEL35504
74146-239-05Instant Gel100 mL in 1 CONTAINERGEL1004
74146-239-06Instant Gel200 mL in 1 CONTAINERGEL2004
74146-239-07Instant Gel946.35 mL in 1 CONTAINERGEL946.354
74146-239-10Instant Gel4 in 1 BOXGEL44
74146-239-11Instant Gel4 in 1 BOXGEL44
74146-239-12Instant Gel4 in 1 BOXGEL44
74146-239-13Instant Gel4 in 1 BOXGEL44
74146-239-14Instant Gel96 in 1 BOXGEL964
74146-239-15Instant Gel24 in 1 BOXGEL244
74146-239-16Instant Gel12 in 1 BOXGEL124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74146-239INSTANT GEL (BENZALKONIUM CHLORIDE) GEL [GM INDUSTRIAL, INC.]4Legacy NDC, 14 package rows20201212_b326d984-287a-7f7d-e053-2995a90aaf13.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74146-23974146-239-01, 74146-239-10, 74146-239-02, 74146-239-11, 74146-239-03, 74146-239-12, 74146-239-04, 74146-239-13, 74146-239-05, 74146-239-14, 74146-239-06, 74146-239-15, 74146-239-07, 74146-239-16

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
NameUNIIKind
LACTIC ACID33X04XA5ATIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
b6210b6a-1bb2-29fc-e053-2a95a90a9bf9b326d984-287a-7f7d-e053-2995a90aaf132020-12-10Boxed warning, WarningsExact identifier
spl id: b6210b6a-1bb2-29fc-e053-2a95a90a9bf9
spl set id: b326d984-287a-7f7d-e053-2995a90aaf13

Reported adverse events (FAERS/openFDA)#

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