FOAMING ANTISEPTIC solution

Foaming Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions: To decrease bacteria on skin, apply a small amount covering hands with product for 30 seconds. Add water, lather and rinse. This product should be used once or twice daily as part of the daily cleaning routine. Children under 6 years of age should be supervised when using this product.

INDICATIONS & USAGE

Uses: Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

ACTIVE INGREDIENT

Active Ingredient: Benzalkonium Chloride 0.13% w/w

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a poison control center.

PURPOSE

Purpose Antibacterial Agent

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl Betaine, PEG-6 Cocamide, Laurtrimonium Chloride, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

WARNINGS

Warnings: For external use only. Contact with eyes should be avoided. In case of contact, immediately flush with water. Stop use and ask a doctor if irritation or rash appears and last more that 72 hours.

PRINCIPAL DISPLAY PANEL

Principal Label

INGREDIENTS AND APPEARANCE

FOAMING ANTISEPTIC 
foaming antiseptic solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64542-683
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64542-683-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	06/09/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/09/2016

Labeler - State Industrial Products (004520987)

Registrant - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(64542-683)