eZ Foam Foaming Antibacterial Hand

eZ Foam Foaming Antibacterial Hand by

Drug Labeling and Warnings

eZ Foam Foaming Antibacterial Hand by is a Otc medication manufactured, distributed, or labeled by Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EZ FOAM FOAMING ANTIBACTERIAL HAND- foaming antibacterial hand soap with aloe and vitamin e 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 Hand

Triclosan 0.5% w/w.......Antibacterial Agent

Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Glycerin, Polyquaternium-7, Aloe Barbadensis Leaf, Tocopheryl Acetate, Disodium Cocamido MIPA-Sulfosuccinate, Tetrasodium EDTA, Fragance, Citric Acid, Polyquaternium-10, DMDM Hydantoin, Yellow 5, Red 33. 

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

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 develop and persists for more than 72 hours.

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

For handwashing to decrease bacteria on skin.

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 develop and persists for more than 72 hours.

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

50865-689-41.jpg

EZ FOAM FOAMING ANTIBACTERIAL HAND 
foaming antibacterial hand soap with aloe and vitamin e solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-689
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)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
EDETATE SODIUM (UNII: MP1J8420LU)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE (UNII: 082Y3WQI5K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50865-689-03	208000 mL in 1 DRUM; Type 0: Not a Combination Product	09/23/2013
2	NDC: 50865-689-09	3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/23/2013
3	NDC: 50865-689-24	1000 mL in 1 BAG; Type 0: Not a Combination Product	09/23/2013
4	NDC: 50865-689-31	1000 mL in 1 BAG; Type 0: Not a Combination Product	09/23/2013
5	NDC: 50865-689-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	09/23/2013
6	NDC: 50865-689-78	950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/23/2013
7	NDC: 50865-689-50	1250 mL in 1 BAG; Type 0: Not a Combination Product	09/23/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/23/2013	10/03/2017

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(50865-689) , analysis(50865-689) , label(50865-689) , pack(50865-689)

Revised: 11/2019

Document Id: 97684b83-7cb1-b027-e053-2a95a90a121a

34390-5

Set id: beb05ef5-f62b-45ef-a1e9-fc49f5f23a4d

Version: 4

Effective Time: 20191115