ANTIBACTERIAL- benzalkonium chloride liquid 
Sante Manufacturing Inc

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.

----------

Benzalkonium Chloride - 0.13%

Purpose - Antibacterial

Uses for handwashing or decrease bacteria to the skin

Stop use and ask a doctor If irritation or redness develops

Warning for external use only

When using this product

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

Direction

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Tetrasodium EDTA, Methylcholoroisothiazolinone, Methylisothiazolinone, Yellow #5 (Cl 19140), Red #4 (Cl 14700)

Spa Soap Antibacterial Liquid Soap 2X Ultra

ANTIBACTERIAL 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71020-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71020-002-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/08/2016
Labeler - Sante Manufacturing Inc (242048747)
Establishment
NameAddressID/FEIBusiness Operations
Sante Manufacturing Inc242048747manufacture(71020-002)

Revised: 10/2016
Document Id: 3e5c387e-7e1e-5998-e054-00144ff88e88
Set id: 3e5c387e-7e1d-5998-e054-00144ff88e88
Version: 1
Effective Time: 20161008
 
Sante Manufacturing Inc