Ezfoam Foaming Antibacterial Moisture Wash (Foaming Antibacterial Handwash) Solution [Kutol Products Company, Inc] -

EZFOAM FOAMING ANTIBACTERIAL MOISTURE WASH (FOAMING ANTIBACTERIAL HANDWASH) SOLUTION [KUTOL PRODUCTS COMPANY, INC]
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NDC	50865-640-17, 50865-640-31, 50865-640-41
Set ID	ca5e348a-1942-4655-baf8-e0ddd19d3b1e
Category	HUMAN OTC DRUG LABEL
Packager	Kutol Products Company, Inc
Generic Name
Product Class
Product Number
Application Number	PART333A

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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

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

Labeler - Kutol Products Company, Inc (004236139)

Registrant - Kutol Products Company, Inc. (004236139)

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

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Medic

EZFOAM FOAMING ANTIBACTERIAL MOISTURE WASH (FOAMING ANTIBACTERIAL HANDWASH) SOLUTION [KUTOL PRODUCTS COMPANY, INC]

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