FOAMING ANTISEPTIC- foaming antiseptic solution 
State Industrial Products

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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State Industrial F683

Directions: To decrease bacteria on skin, apply a small amount covering hands with product for 30 seconds. Add water, lather and rinse. This product should be used once or twice daily as part of the daily cleaning routine. Children under 6 years of age should be supervised when using this product.

Uses: Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Active Ingredient: Benzalkonium Chloride 0.13% w/w

Keep out of reach of children. If swallowed, get medical help or contact a poison control center.

Purpose Antibacterial Agent

Inactive Ingredients: Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl Betaine, PEG-6 Cocamide, Laurtrimonium Chloride, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

Warnings: For external use only. Contact with eyes should be avoided. In case of contact, immediately flush with water. Stop use and ask a doctor if irritation or rash appears and last more that 72 hours.

State LabelPrincipal Label

FOAMING ANTISEPTIC 
foaming antiseptic solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64542-683
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.013 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64542-683-411000 mL in 1 BAG; Type 0: Not a Combination Product06/09/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/09/2016
Labeler - State Industrial Products (004520987)
Registrant - Kutol Products Company (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company004236139manufacture(64542-683)

Revised: 8/2023
Document Id: 03a8bd37-d221-2a2d-e063-6294a90a0406
Set id: a07155c1-d120-5050-e053-2995a90a84d2
Version: 4
Effective Time: 20230824
 
State Industrial Products