EZFOAM FOAMING ANTIBACTERIAL MOISTURE WASH- foaming antibacterial handwash solution
Kutol Products Company, Inc

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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eZ Foam Foaming Antibacterial Moisture Wash

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

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.

For handwashing to decrease bacteria on skin

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.

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

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.

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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	Marketing End Date
Packaging
1	NDC:50865-640-17	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/06/2014	10/03/2017
2	NDC:50865-640-31	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/06/2014	10/03/2017
3	NDC:50865-640-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/06/2014	10/03/2017
4	NDC:50865-640-21	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/06/2014	10/03/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/06/2014	10/03/2017

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)

Revised: 10/2020

Document Id: b11b77a1-dcaa-663b-e053-2995a90a61bd

Set id: ca5e348a-1942-4655-baf8-e0ddd19d3b1e

Version: 4

Effective Time: 20201007

Kutol Products Company, Inc