E3 ALCOHOL FREE FOAMING SANITIZER- benzalkonium chloride soap

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Betco Corporation, Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
65601-779-03, 65601-779-04, 65601-779-05, 65601-779-29, 65601-779-55

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

E3 ALCOHOL FREE FOAMING SANITIZER

benzalkonium chloride soap

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 56 0 1-779

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

1 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CETRIMO NIUM CHLO RIDE (UNII: UC9 PE9 5IBP)

LAURTRIMO NIUM CHLO RIDE (UNII: A8 1MSI0 FIC)

DIHYDRO XYETHYL CO CAMINE O XIDE (UNII: 8 AR51R3BL5)

Betco Corporation, Ltd.

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 56 0 1-779 -0 4 378 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 16

2

NDC:6 56 0 1-779 -0 5 120 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 16

0 7/15/20 20

3

NDC:6 56 0 1-779 -0 3 750 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 16

0 7/15/20 20

4

NDC:6 56 0 1-779 -29

10 0 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 16

5

NDC:6 56 0 1-779 -55

20 8 18 mL in 1 DRUM; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 1/0 1/20 16

Labeler -

Betco Corporation, Ltd. (024492831)

Registrant -

Betco Corporation, Ltd. (024492831)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Betco Co rpo ratio n, Ltd.

0 2449 28 31 manufacture(6 56 0 1-779 ) , pack(6 56 0 1-779 ) , label(6 56 0 1-779 ) , analysis(6 56 0 1-779 )

Revised: 9/2020

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