70% ALCOHOL HAND SANITIZER- alcohol soap 
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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70% Alcohol Hand Sanitizer Gel

Ethyl Alcohol 70% v/v.....Antibacterial Agent

Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Triisopropanolamine

For handwashing to help reduce bacteria on the skin

For external use only.

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.

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

Apply to hair or body. Work into a rich lather. Massage hair and body completely for at least 30 seconds. Rinse thoroughly. Dry completely.

For handwashing to help reduce bacteria on the skin.

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.

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

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

label

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70% ALCOHOL HAND SANITIZER 
alcohol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-074
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.07 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50865-074-416 in 1 PACKET02/27/2018
11000 mL in 1 BAG; Type 0: Not a Combination Product
2NDC:50865-074-444 in 1 PACKET02/27/2018
21000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/27/2018
Labeler - Kutol Products Company, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc.004236139manufacture(50865-074) , analysis(50865-074) , label(50865-074) , pack(50865-074)

Revised: 2/2018
Document Id: 66afb1d0-0726-7c1a-e053-2a91aa0aadad
Set id: 6648af79-8256-328a-e053-2a91aa0a9157
Version: 2
Effective Time: 20180226
 
Kutol Products Company, Inc.