ANTIBACTERIAL FOAMING SKIN CLEANSER- benzalkonium chloride soap 
Betco Corporation, Ltd.

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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Antibacterial Foaming Skin Cleanser

​Active Ingredient

​Benzalkonium Chloride 0.13%

Uses

Warnings

Directions

Inactive Ingredients

​Water, Potasium Cocoate, Propylene Glycol, Glycerin, Tetrasodium EDTA, Fragrance, Bronopol, Sodium Citrate, Magnesium Nitrate, Sodium Hydroxyacetate, Ethanol, Aloe Barbadensis Leaf Juice, Trisodium Nitriloacetate, FD&C Yellow #5, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red #40.

Purpose

Antibacterial

KEEP OUT OF REACH OF CHILDREN

045529

ANTIBACTERIAL FOAMING SKIN CLEANSER 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-709
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GERANIOL (UNII: L837108USY)  
2-TERT-BUTYLCYCLOHEXYLOXYBUTANOL (UNII: 1DR20642YH)  
DIHYDROMYRCENOL (UNII: 46L1B02ND9)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ALLYL HEPTANOATE (UNII: AU4CYG9V68)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913)  
CITRAL (UNII: T7EU0O9VPP)  
N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 9U1Q4T4ZYS)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65601-709-291000 mL in 1 BAG; Type 0: Not a Combination Product07/19/2017
2NDC:65601-709-55208000 mL in 1 DRUM; Type 0: Not a Combination Product07/19/2017
3NDC:65601-709-043780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/19/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/19/2017
Labeler - Betco Corporation, Ltd. (024492831)
Registrant - Betco Corporation, Ltd. (024492831)
Establishment
NameAddressID/FEIBusiness Operations
Betco Corporation, Ltd.024492831manufacture(65601-709) , pack(65601-709) , label(65601-709)

Revised: 9/2020
Document Id: af0b3d41-492b-51b4-e053-2995a90adc90
Set id: e5cb1df5-1e13-4a0b-939e-071c577bcf15
Version: 6
Effective Time: 20200911
 
Betco Corporation, Ltd.