GEL- antibacterial hand soap gel

gel by

Drug Labeling and Warnings

gel by is a Otc medication manufactured, distributed, or labeled by Commercial Beverage Concepts LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alkyl Dimethyl Benzyl Ammonium Chloride 0.5%

PURPOSE

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

WARNINGS

• 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

Directions:

• Wet hands
• Rinse well and dry hands completely

INACTIVE INGREDIENT

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:

If swallowed, get medical help, or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Apply small amount of product and work into a lather

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GEL 
antibacterial hand soap gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75594-190
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	5 kg  in 1000 kg

Inactive Ingredients
Ingredient Name	Strength
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM SULFATE (UNII: 0YPR65R21J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75594-190-08	0.227 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/22/2022
2	NDC: 75594-190-28	3.63 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/22/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/22/2022

Labeler - Commercial Beverage Concepts LLC (080925174)

Establishment
Name	Address	ID/FEI	Business Operations
Commercial Beverage Concepts LLC		080925174	manufacture(75594-190) , label(75594-190) , pack(75594-190)