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Antibacterial Hand Cleaner with Aloe and Vitamin E

Dosage form: solution
Ingredients: TRICLOSAN 0.3g in 100mL
Labeler: Kutol Products Company, Inc.
NDC Code: 50865-650

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-650
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
AMMONIUM LAURYL SULFATE 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL HYDROXYSULTAINE 
DMDM HYDANTOIN 
SODIUM CHLORIDE 
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C YELLOW NO. 5 
GLYCERIN 
EDETATE SODIUM 
ALPHA-TOCOPHEROL ACETATE 
ALOE VERA LEAF 
ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE 
Packaging
#Item CodePackage Description
1NDC:50865-650-361000 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/11/2013
Labeler - Kutol Products Company, Inc. (004236139)
Registrant - Kutol Producs Company, Inc. (004236139)
Establishment
NameAddressID/FEIOperations
Kutol Products Company, Inc.004236139manufacture(50865-650), analysis(50865-650), label(50865-650), pack(50865-650)

Revised: 04/2014
 
Kutol Products Company, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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