FDA.reportPublic FDA data

b.clean hand sanitizer (foam)

Manufacturer
Marque of Brands Americas, LLC
Effective date
2024-07-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:59:47

Label at a glance#

Productb.clean hand sanitizer (foam)
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride

Purpose

OTC - PURPOSE SECTION

Antimicrobial

DOSAGE & ADMINISTRATION SECTION

  • 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.

INACTIVE INGREDIENT SECTION

Water (Aqua), Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol,Tocopheryl Acetate, Squalane, Dihydroxypropyl PEG-5 Linoleammonium Chloride, Disodium Laureth Sulfosuccinate, Sodium Cocoyl Isethionate, Cocamidopropyl Betaine, Sodium Methyl Cocoyl Taurate, Phenoxyethanol, Citric Acid, Fragrence

Warning

WARNINGS SECTION

  • Flammable, keep away from flame.
  • For External Use Only.

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.

OTC - WHEN USING SECTION

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse throughly with water.

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - STOP USE SECTION

and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTHER SAFETY INFORMATION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73978-002B.CLEAN HAND SANITIZER (FOAM) (ALCOHOL) GEL [MARQUE OF BRANDS AMERICAS, LLC]3Legacy NDC20240703_a22af54a-c00f-ab8b-e053-2a95a90a8862.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73978-00273978-002-01, 73978-002-02, 73978-002-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
SQUALANEGW89575KF9IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE0Y0NQR2GH1IACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT

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
3d473081-60ee-209c-e063-6394a90a863ea22af54a-c00f-ab8b-e053-2a95a90a88622025-08-26WarningsExact identifier
spl set id: a22af54a-c00f-ab8b-e053-2a95a90a8862

Reported adverse events (FAERS/openFDA)#

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