GEL- antibacterial hand soap gel 
Commercial Beverage Concepts LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alkyl Dimethyl Benzyl Ammonium Chloride 0.5%

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

When using this product:

Stop use and ask a doctor if:

Directions:

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

Keep out of reach of children:

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

Apply small amount of product and work into a lather

8oz label gallon label

GEL 
antibacterial hand soap gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75594-190
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE5 kg  in 1000 kg
Inactive Ingredients
Ingredient NameStrength
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75594-190-080.227 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/22/2022
2NDC:75594-190-283.63 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/22/2022
Labeler - Commercial Beverage Concepts LLC (080925174)
Establishment
NameAddressID/FEIBusiness Operations
Commercial Beverage Concepts LLC080925174manufacture(75594-190) , label(75594-190) , pack(75594-190)

Revised: 8/2022
Document Id: e6db2ef0-0c4d-2b70-e053-2995a90aab19
Set id: e6db2ef0-0c4c-2b70-e053-2995a90aab19
Version: 1
Effective Time: 20220822
 
Commercial Beverage Concepts LLC