FOAMING SANITIZING HAND- alcohol soap 
Kutol Products Company

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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F710F

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.

image description

FOAMING SANITIZING HAND 
alcohol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-710
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.072 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50865-710-411000 mL in 1 BAG; Type 0: Not a Combination Product12/01/2015
2NDC:50865-710-1750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2015
3NDC:50865-710-441000 mL in 1 BAG; Type 0: Not a Combination Product10/01/2015
4NDC:50865-710-551200 mL in 1 BAG; Type 0: Not a Combination Product10/01/2015
5NDC:50865-710-91532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/01/2015
Labeler - Kutol Products Company (004236139)
Registrant - Kutol Products Company (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company004236139manufacture(50865-710)

Revised: 8/2023
Document Id: 0337689b-c5e9-d881-e063-6394a90aaec9
Set id: b2e22e51-88f5-4391-8705-3855c1645d80
Version: 7
Effective Time: 20230818
 
Kutol Products Company