DIRECT EFFECT E-2- 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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Direct Effect E-2

Direct Effect E-2

​Active Ingredient

Benzalkonium Chloride 2.5%

Direct Effect E-2

Uses

  • Use in meat and poultry plants, food processing plants, supermarkets, restaurants and other food service operations.

Direct Effect E-2

Warnings

  • For external use only.
  • Harmful if swallowed.
  • Avoid contact with eyes.
  • Children under the age of 6 should be supervised by an adult when using this product.
  • Discontinue use is irritation or redness develops.
  • If irritation persists for more than 72 hours, consult a physician.
  • If swallowed call a physician.
  • KEEP OUT OF REACH OF CHILDREN.

Direct Effect E-2

Directions

  • ​Read the entire label before using this product.
  • ​Dispense 2 pumps of product in hands, lather and wash in normal manner.
  • After use, hands must be rinsed with potable water.
  • Repeat whenever re-entering production areas.

Direct Effect E-2

Inactive Ingredients

​Water, Cocamidopropyl Betaine, PEG-6 Cocamidopropylamine Oxide, Hydroxyethylcellulose.

Direct Effect E-2

Questions or Comments?Phone: (800) 777-9343

MDS information:​(800) 891-4965

Direct Effect E-2

Purpose

Antibacterial

Direct Effect E-2

KEEP OUT OF REACH OF CHILDREN

Direct Effect E-2

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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DIRECT EFFECT E-2 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-170
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65601-170-043780 mL in 1 JUG; Type 0: Not a Combination Product11/12/201203/25/2019
2NDC:65601-170-19900 mL in 1 BAG; Type 0: Not a Combination Product11/12/201203/25/2019
3NDC:65601-170-55208 mL in 1 DRUM; Type 0: Not a Combination Product11/12/201203/25/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/12/201203/25/2019
Labeler - Betco Corporation, Ltd. (024492831)
Registrant - Betco corporation, Ltd. (024492831)
Establishment
NameAddressID/FEIBusiness Operations
Betco Corporation, Ltd.024492831manufacture(65601-170)

Revised: 3/2019
 
Betco Corporation, Ltd.