E3 Alcohol Free Foaming Sanitizer

E3 ALCOHOL FREE FOAMING SANITIZER- benzalkonium chloride soap
Betco Corporation, Ltd.

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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E3 ALCOHOL FREE FOAMING SANITIZER
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65601-779
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65601-779-04	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2016
2	NDC:65601-779-05	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2016	07/15/2020
3	NDC:65601-779-03	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2016	07/15/2020
4	NDC:65601-779-29	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/01/2016
5	NDC:65601-779-55	20818 mL in 1 DRUM; Type 0: Not a Combination Product	01/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/2016

Labeler - Betco Corporation, Ltd. (024492831)

Registrant - Betco Corporation, Ltd. (024492831)

Name	Address	ID/FEI	Business Operations
Establishment
Betco Corporation, Ltd.		024492831	manufacture(65601-779) , pack(65601-779) , label(65601-779) , analysis(65601-779)