Foaming E2 Sanitizing Hand by RJ Schinner / Kutol Products Company

Foaming E2 Sanitizing Hand by

Drug Labeling and Warnings

Foaming E2 Sanitizing Hand by is a Otc medication manufactured, distributed, or labeled by RJ Schinner, Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FOAMING E2 SANITIZING HAND- benzalkonium chloride soap 
RJ Schinner

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.

----------

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antibacterial

Keep out of reach of children. If swallowed, contact a physician or poison control center. 

Uses For handwashing to decrease bacteria on skin

Directions Apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

Warnings

For external use only. Do not use in the eyes. If eye contact occurs, flush eyes with water.

Stop use and ask a doctor if redness and irritation occur and last for more than 72 hours.

Inactive Ingredients

water,  cocamidopropyl PG-dimonium chloride phosphate,cocamidopropyl betaine, PEG-6 cocamide, laurtrimonium chloride, iodopropynyl butylcarbamate,methylisothiazolinone.

FOAMING E2 SANITIZING HAND 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71303-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.003 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71303-002-01	4000 mL in 1 DRUM; Type 0: Not a Combination Product	03/10/2017	01/27/2020
2	NDC: 71303-002-02	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/10/2017	01/27/2020
3	NDC: 71303-002-03	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/10/2017	01/27/2020
4	NDC: 71303-002-04	950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/10/2017	01/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/10/2017	01/27/2020

Labeler - RJ Schinner (023432909)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(71303-002) , analysis(71303-002) , sterilize(71303-002) , pack(71303-002)

Revised: 1/2020

Document Id: 9d2561ea-4f1f-1050-e053-2995a90a9a7a

34390-5

Set id: 4999b1e5-a620-4182-e054-00144ff8d46c

Version: 2

Effective Time: 20200127

 

RJ Schinner