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Foaming Sanitizing Hand by Kutol Products Company

Dosage form: soap
Ingredients: ALCOHOL 0.072mg in 1mL
Labeler: Kutol Products Company
NDC Code: 50865-710

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.

Active Ingredient

Ethyl Alcohol 72% v/v

Purpose

Antibacterial

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

Uses Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Directions To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.

Warnings

For external use only.

FLAMMABLE. Keep away from heat or flames.

Avoid contact with eyes. If eye contact occurs, flush eyes with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Inactive Ingredients

water,  cocamidopropyl PG-dimonium chloride phosphate,cocamidopropyl betaine, PEG-6 cocamide, laurtrimonium chloride, iodopropynyl butylcarbamate,methylisothiazolinone.

FOAMING SANITIZING HAND 
alcohol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-710
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL0.072 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALOE VERA LEAF 
PEG-10 DIMETHICONE (600 CST) 
EDETATE DISODIUM 
GLYCERIN 
ISOPROPYL MYRISTATE 
POLYQUATERNIUM-11 (1000000 MW) 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:50865-710-411000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/01/2015
Labeler - Kutol Products Company (004236139)
Establishment
NameAddressID/FEIOperations
Kutol Products Company004236139manufacture(50865-710)

Revised: 04/2016
 
Kutol Products Company

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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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