E2 ANTIBACTERIAL FOAMING SKIN CLEANSER- 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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E2 Antibacterial Foaming Skin Cleanser

Active Ingredient

Benzalkonium Chloride 0.13%

E2 Antibacterial Foaming Skin Cleanser

Uses

For handwashing to decrease the bacteria on the skin.
Recommended for repeated use.

E2 Antibacterial Foaming Skin Cleanser

Warnings

For external use only.
When using this product avoid contact with eyes. In case of contact flush with water
Discontinue use is irritation or redness develops.
Stop use and ask a doctor If irritation persists for more than 72 hours, or if condition persists for more than 72 hours.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact Poison Control Center right away.

E2 Antibacterial Foaming Skin Cleanser

Directions

Read the entire label before using this product.
Dispense 2 pumps of product in hands and scrub thoroughly over all surfaces of both hands for 15 seconds. Rinse with clean water.

E2 Antibacterial Foaming Skin Cleanser

Inactive Ingredients

Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide, citric acid.

E2 Antibacterial Foaming Skin Cleanser

Purpose

Antimicrobial

E2 Antibacterial Foaming Skin Cleanser

KEEP OUT OF REACH OF CHILDREN

E2 Antibacterial Foaming Skin Cleanser

E2 ANTIBACTERIAL FOAMING SKIN CLEANSER
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65601-817
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65601-817-04	3780 mL in 1 JUG; Type 0: Not a Combination Product	01/17/2014
2	NDC:65601-817-29	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/17/2014
3	NDC:65601-817-03	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2014	09/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/17/2014

Labeler - Betco Corporation, Ltd. (024492831)

Registrant - Betco corporation, Ltd. (024492831)

Name	Address	ID/FEI	Business Operations
Establishment
Betco Corporation, Ltd.		005050158	manufacture(65601-817)

Name	Address	ID/FEI	Business Operations
Establishment
Betco Corportation, Ltd.		024492831	label(65601-817) , pack(65601-817) , manufacture(65601-817)