FOAMING ANTIBACTERIAL HAND WASH- 0.13% benzalkonium chloride soap 
RJ Schinner

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.

----------

RJ Schninner F213F

Dosage and Administration

Directions Apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

Inactive Ingredients

Inactive Ingredients Water, Cocamidopopyl Betaine, Cocamidoprpyl PG-Dimonium Chloride Phosphate, PEG-6 Cocamide, Laurtrimonium Chloride, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Fragrance, Iodopropynyl Butylcarbamate, Methylisothiazolinone, Yellow 5, Red 33.

Indications and Uses

Uses For handwashing to decrease bacteria on the skin.

Keep Out Of Reach Of Children

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

Purpose Section

Purpose Antibacterial Agent

Active Ingredient Section

Active Ingredient Benzalkonium Chloride 0.13% w/w

Warnings Section

Warnings

For external use only

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

Stop use and ask a doctor if, in rare instances, redness or irritation develops and persists for more than 72 hours

Primary Display Label

Primary Display Label

FOAMING ANTIBACTERIAL HAND WASH 
0.13% benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71303-213
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
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
HC YELLOW NO. 5 (UNII: I844A312T7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71303-213-311000 mL in 1 BAG; Type 0: Not a Combination Product03/30/2017
2NDC:71303-213-411000 mL in 1 BAG; Type 0: Not a Combination Product03/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/30/2017
Labeler - RJ Schinner (023432909)
Registrant - Kutol Products, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products, Inc.004236139manufacture(71303-213)

Revised: 8/2023
Document Id: 03a8fa2d-97aa-9f63-e063-6394a90afe68
Set id: 9cbbd5d5-02cb-7119-e053-2995a90a1905
Version: 6
Effective Time: 20230824
 
RJ Schinner