FOAMING SANITIZING HAND- benzalkonium chloride soap

Foaming Sanitizing Hand by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzalkonium Chloride 0.13% w/w

PURPOSE

Purpose

Antibacterial

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses For handwashing to decrease bacteria on skin

DOSAGE & ADMINISTRATION

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

WARNINGS

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 INGREDIENT

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOAMING SANITIZING HAND 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-683
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: 50865-683-03	4000 mL in 1 DRUM; Type 0: Not a Combination Product	10/01/2015	06/10/2017
2	NDC: 50865-683-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	10/01/2015
3	NDC: 50865-683-78	950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2015	06/10/2017
4	NDC: 50865-683-44	1000 mL in 1 BAG; Type 0: Not a Combination Product	06/12/2016
5	NDC: 50865-683-17	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/12/2016
6	NDC: 50865-683-04	1000 mL in 1 BAG; Type 0: Not a Combination Product	06/12/2017
7	NDC: 50865-683-09	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2015	06/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/01/2015

Labeler - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(50865-683)