ANTIBACTERIAL HAND CLEANER WITH ALOE AND VITAMIN E- 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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Antibacterial Hand Soap with Aloe and Vitamin E

Triclosan 0.3% w/w.........Antibacterial Agent

Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Hydroxysultaine, Disodium Cocamido MIPA-Sulfosuccinate, Glycerin, Fragrance, Citric Acid, Tetrasodium EDTA, DMDM Hydantoin, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Yellow 5, Red 33.

For handwashing to decrease bacteria on skin.

For external use only.

Do not use in the eyes. If this occurs, flush eyes with water.

Stop use if redness or irritation occurs. If condition persists for more than 72 hours, consult a physician.

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

Apply small amount, covering hands with product for 30 seconds. Add water, lather and rinse.

For handwashing to decrease bacteria on skin.

For external use only.

Do not use in the eyes. If this occurs, flush eyes with water.

Stop use if redness or irritation occurs. If condition persists for more than 72 hours, consult a physician.

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

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

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ANTIBACTERIAL HAND CLEANER WITH ALOE AND VITAMIN E
antibacterial hand soap with aloe and vitamin e solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50865-650
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE SODIUM (UNII: MP1J8420LU)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE (UNII: 082Y3WQI5K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50865-650-36	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/11/2013	10/03/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/11/2013	10/03/2017

Labeler - Kutol Products Company, Inc. (004236139)

Registrant - Kutol Producs Company, Inc. (004236139)

Name	Address	ID/FEI	Business Operations
Establishment
Kutol Products Company, Inc.		004236139	manufacture(50865-650) , analysis(50865-650) , label(50865-650) , pack(50865-650)

Revised: 10/2021

Document Id: cddd8cd9-ecc3-02e6-e053-2995a90a4b7a

Set id: d9058a96-823d-4ec3-b28f-7bc819e73d72

Version: 8

Effective Time: 20211008

Kutol Products Company, Inc.