FDA.reportPublic FDA data

0.13% Benzalkonium Chloride Instant Hand sanitizer

Manufacturer
BJ Goods LLC
Effective date
2020-07-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:04

Label at a glance#

Product0.13% Benzalkonium Chloride Instant Hand sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Keep out of reach of childrenKeep out of reach of children

INDICATIONS & USAGE SECTION

Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Indications & Usage SectionIndications & Usage Section

OTC - PURPOSE SECTION

Use: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

PurposePurpose

DOSAGE & ADMINISTRATION SECTION

Dosage form: Gel

Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

DosageDosage

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% v/v

Active IngredientActive Ingredient

WARNINGS SECTION

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

WarningsWarnings

Do not use: In children less than 2 months of age. On open skin wounds.

Do not useDo not use

When using this product: Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

warnings_1warnings_1

Stop use and ask a doctor if: irritation or rash occurs. These may by signs o a serious condition.

Stop useStop use

INACTIVE INGREDIENT SECTION

Aloe, glycerin, sterile distilled water

Inactive IngredientsInactive Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anti-Bacterial Hand Sanitizer (Disinfectant Gel) free - alcohol

3.8L label NDC: 79635-019-05

3.8L Label3.8L Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 ml label NDC:79635-019-01

100 ml label NDC: 79635-019-02

240 ml label NDC: 79635-019-03

500 ml label NDC: 79635-019-04

60/100/240/500 ml labels60/100/240/500 ml labels

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79635-019-012022-01-28C16284748780-1d6a99b39-9317-a426-e053-dadaa90af4c2a9a6b624-d6d9-8373-e053-2a95a90a85e3
79635-019-022022-01-28C16284748780-1d6a99b39-9317-a426-e053-dadaa90af4c2a9a6b624-d6d9-8373-e053-2a95a90a85e3
79635-019-032022-01-28C16284748780-1d6a99b39-9317-a426-e053-dadaa90af4c2a9a6b624-d6d9-8373-e053-2a95a90a85e3
79635-019-042022-01-28C16284748780-1d6a99b39-9317-a426-e053-dadaa90af4c2a9a6b624-d6d9-8373-e053-2a95a90a85e3
79635-019-052022-01-28C16284748780-1d6a99b39-9317-a426-e053-dadaa90af4c2a9a6b624-d6d9-8373-e053-2a95a90a85e3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79635-019-010.13% Benzalkonium Chloride Instant Hand sanitizer60 mL in 1 BOTTLE, PUMPGEL601
79635-019-020.13% Benzalkonium Chloride Instant Hand sanitizer100 mL in 1 BOTTLE, PUMPGEL1001
79635-019-030.13% Benzalkonium Chloride Instant Hand sanitizer240 mL in 1 BOTTLE, PUMPGEL2401
79635-019-040.13% Benzalkonium Chloride Instant Hand sanitizer500 mL in 1 BOTTLE, PUMPGEL5001
79635-019-050.13% Benzalkonium Chloride Instant Hand sanitizer3800 mL in 1 BOTTLE, PUMPGEL38001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79635-0190.13% BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER (HAND SANITIZER) GEL [BJ GOODS LLC]1Legacy NDC, 5 package rows20200819_a9a6b624-d6d9-8373-e053-2a95a90a85e3.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79635-01979635-019-03, 79635-019-04, 79635-019-01, 79635-019-05, 79635-019-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZETHONIUM CHLORIDEPH41D05744IACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
a9a6b624-d6da-8373-e053-2a95a90a85e3a9a6b624-d6d9-8373-e053-2a95a90a85e32020-07-07WarningsExact identifier
spl id: a9a6b624-d6da-8373-e053-2a95a90a85e3
spl set id: a9a6b624-d6d9-8373-e053-2a95a90a85e3

Reported adverse events (FAERS/openFDA)#

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