F683F Foaming sanitizing soap

FOAMING SANITIZING HAND- benzalkonium chloride soap
Kutol Products Company

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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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.

image description

FOAMING SANITIZING HAND
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50865-683
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/01/2015

Labeler - Kutol Products Company (004236139)

Registrant - Kutol Products Company (004236139)

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