FDA.reportPublic FDA data

gel

Manufacturer
Commercial Beverage Concepts LLC
Effective date
2022-08-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:30

Label at a glance#

Productgel
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alkyl Dimethyl Benzyl Ammonium Chloride 0.5%

OTC - PURPOSE SECTION

For hand-washing to decrease bacteria on the skin. Rocommended for repeated use.

WARNINGS SECTION

  • For external use only: hands
  • Do not use if you are allergic to any of the ingedients listed below

When using this product:

  • avoid contact with eyes. In case of eye contact, flush thoroughly with water

Stop use and ask a doctor if:

  • irritation and redness develop

INDICATIONS & USAGE SECTION

Directions:

  • Wet hands
  • Rinse well and dry hands completely

INACTIVE INGREDIENT SECTION

Water, Sodium Olefin Sulfonate, Lauramine Oxide, Dimethyletradecylamine Oxide, Sodium Sulfonate, Cocamide DEA, Glycerin, Diethanolamine, Citric Acid, Fragrance, Dye

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

Apply small amount of product and work into a lather

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8oz label8oz labelgallon labelgallon label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75594-190-082024-01-30C16284748780-11030e365-1bd1-111a-e063-dadaa90a10e2e6db2ef0-0c4c-2b70-e053-2995a90aab19
75594-190-282024-01-30C16284748780-11030e365-1bd1-111a-e063-dadaa90a10e2e6db2ef0-0c4c-2b70-e053-2995a90aab19

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75594-190-08gel0.227 kg in 1 BOTTLE, PUMPGEL0.2271
75594-190-28gel3.63 kg in 1 BOTTLE, PLASTICGEL3.631

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75594-190GEL (ANTIBACTERIAL HAND SOAP) GEL [COMMERCIAL BEVERAGE CONCEPTS LLC]1Legacy NDC, 2 package rows20220823_e6db2ef0-0c4c-2b70-e053-2995a90aab19.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75594-19075594-190-08, 75594-190-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LAURAMINE OXIDE4F6FC4MI8WIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
SODIUM SULFATE0YPR65R21JIACT

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
e6db2ef0-0c4d-2b70-e053-2995a90aab19e6db2ef0-0c4c-2b70-e053-2995a90aab192022-08-22WarningsExact identifier
spl id: e6db2ef0-0c4d-2b70-e053-2995a90aab19
spl set id: e6db2ef0-0c4c-2b70-e053-2995a90aab19

Reported adverse events (FAERS/openFDA)#

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