ANTIBACTERIAL- benzalkonium chloride soap 
Uline

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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ULine F640F

Inactive Ingredient Section

Indications and Usage Section

OTC Keep out of Reach of Children Section

OTC Purpose Section

OTC Active Ingredient Section

Warnings Section

Dosage

Label Example

ANTIBACTERIAL 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69790-640
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
AMINO ACIDS, WHEAT (UNII: 0370GZL32F)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
WATER (UNII: 059QF0KO0R)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorCITRUSImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69790-640-073785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/12/2017
2NDC:69790-640-241000 mL in 1 BAG; Type 0: Not a Combination Product09/12/2017
3NDC:69790-640-311000 mL in 1 BAG; Type 0: Not a Combination Product09/12/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/12/2017
Labeler - Uline (039612668)
Registrant - Kutol Products Company (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company004236139manufacture(69790-640)

Revised: 8/2023
Document Id: 03a8a3c7-0f60-277e-e063-6294a90ac88d
Set id: 92730c66-127f-c90b-e053-2995a90a4823
Version: 8
Effective Time: 20230824
 
Uline