FOAMING ANTIBACTERIAL HAND WASH- 0.13% benzalkonium chloride soap

Foaming Antibacterial Hand Wash by

Drug Labeling and Warnings

Foaming Antibacterial Hand Wash by is a Otc medication manufactured, distributed, or labeled by RJ Schinner, Kutol Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage and Administration

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

Inactive Ingredients

Inactive Ingredients Water, Cocamidopopyl Betaine, Cocamidoprpyl PG-Dimonium Chloride Phosphate, PEG-6 Cocamide, Laurtrimonium Chloride, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Fragrance, Iodopropynyl Butylcarbamate, Methylisothiazolinone, Yellow 5, Red 33.

Indications and Uses

Uses For handwashing to decrease bacteria on the skin.

Keep Out Of Reach Of Children

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

Purpose Section

Purpose Antibacterial Agent

Active Ingredient Section

Active Ingredient Benzalkonium Chloride 0.13% w/w

Warnings Section

Warnings

For external use only

Avoid contact with eyes. If contact occurs, flush with water.

Stop use and ask a doctor if, in rare instances, redness or irritation develops and persists for more than 72 hours

Primary Display Label

INGREDIENTS AND APPEARANCE

FOAMING ANTIBACTERIAL HAND WASH 
0.13% benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71303-213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.013 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)
HC YELLOW NO. 5 (UNII: I844A312T7)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71303-213-31	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2017
2	NDC: 71303-213-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/30/2017

Labeler - RJ Schinner (023432909)

Registrant - Kutol Products, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products, Inc.		004236139	manufacture(71303-213)