FOAMING ADVANCED ANTIBACTERIAL HAND- benzalkonium chloride 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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F213F Foaming advanced antibacterial soap

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antibacterial

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

Uses Handwash to help decrease bacteria on the skin

Directions To decrease bacteria on the skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

Warnings

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 develops. If condition persists for more than 72 hours, consult a physician.

Inactive Ingredients

water, cocamidopropyl betaine, cocamidopropyl PG-dimonium chloride phosphate, PEG-6 cocamide, laurtrimonium chloride, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), fragrance, iodopropynyl butylcarbamade, methylisothiazolinone, yellow 5, red 33.

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FOAMING ADVANCED ANTIBACTERIAL HAND 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-213
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.003 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50865-213-241000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/201506/20/2017
2NDC:50865-213-411000 mL in 1 BAG; Type 0: Not a Combination Product10/01/2015
3NDC:50865-213-501200 mL in 1 BAG; Type 0: Not a Combination Product10/01/2015
4NDC:50865-213-78950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2015
5NDC:50865-213-133785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2015
6NDC:50865-213-1750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2015
7NDC:50865-213-521000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2015
Labeler - Kutol Products Company (004236139)
Registrant - Kutol Products Company (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company004236139manufacture(50865-213)

Revised: 8/2023
Document Id: 03379280-d49d-081d-e063-6394a90a9c6e
Set id: 7abc56b5-4446-4464-9b94-6c55f8bb9b74
Version: 8
Effective Time: 20230818
 
Kutol Products Company