EZFOAM FOAMING ANTIBACTERIAL MOISTURE WASH- foaming antibacterial handwash solution

eZFoam Foaming Antibacterial Moisture Wash by

Drug Labeling and Warnings

eZFoam Foaming Antibacterial Moisture Wash by is a Otc medication manufactured, distributed, or labeled by Kutol Products Company, Inc, Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Triclosan 0.5% w/w.....Antibacterial Handwashing

INACTIVE INGREDIENT

Water, Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Peg-80 Glyceryl Cocoate, Disodium Cocoamphodiacetate, Cocamide MEA, Aloe Barbadensis Leaf Juice, Fragrance, Sodium Chloride, Citric Acid, Dimethicone, Glutamic Acid, Leucine, Serine, Phenylalanine, Proline, Glycine, Valine, Isoleucine, Arginine, Tocopheryl Acetate, Tetrasodium EDTA, Quaternium-15, Propylene Glycol, Red 33.

PURPOSE

For handwashing to decrease bacteria on skin

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 over 72 hours.

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

DOSAGE & ADMINISTRATION

To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

INDICATIONS & USAGE

For handwashing to decrease bacteria on skin.

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 over 72 hours.

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

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

  50865-640-17.jpg

PRINCIPAL DISPLAY PANEL

  50865-640-31.jpg

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EZFOAM FOAMING ANTIBACTERIAL MOISTURE WASH 
foaming antibacterial handwash solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-640
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	18.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)
QUATERNIUM-15 (UNII: E40U03LEM0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINO ACIDS (UNII: 0O72R8RF8A)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE SODIUM (UNII: MP1J8420LU)
PEG-80 GLYCERYL COCOATE (UNII: A7D04GUR0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50865-640-17	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/06/2014
2	NDC: 50865-640-31	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/06/2014
3	NDC: 50865-640-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/06/2014
4	NDC: 50865-640-21	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/06/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/06/2014

Labeler - Kutol Products Company, Inc (004236139)

Registrant - Kutol Products Company, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc.		004236139	manufacture(50865-640) , analysis(50865-640) , label(50865-640) , pack(50865-640)