NDC Code(s) : 65601-170-04, 65601-170-19, 65601-170-55
Packager : Betco Corporation, Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Direct Effect E-2Benzalkonium Chloride SOAP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65601-170
Route of Administration Topical DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
(BENZALKONIUM - UNII:7N6JUD5X6Y) 		BENZALKONIUM CHLORIDE25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
PEG-6 COCAMIDE(UNII: YZ6NLA4O1E)
COCAMIDOPROPYLAMINE OXIDE(UNII: M4SL82J7HK)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)(UNII: ZYD53NBL45)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65601-170-043780 mL in 1 JUG
2NDC:65601-170-19900 mL in 1 BAG
3NDC:65601-170-55208 mL in 1 DRUM
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 11/12/2012

PRINCIPAL DISPLAY PANEL

Direct Effect E-2

One Step Hand Cleaner and Sanitizer for the Food Industry

Net Contents: 1 gallon (U.S./E.U.) 3.78 L

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