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.

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Spa Soap: Antibacterial Soap

Benzalkonium Chloride - 0.13%......................Purpose - Antibacterial

Purpose - Antibacterial

Uses for handwashing or decrease bacteria to the skin

For external use only

Stop use and ask a doctor if irritation or redness develops

When using the product

Keep out of reach of children

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

Directions

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl14700)

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ANTIBACTERIAL 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71020-100
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
GLYCERIN (UNII: PDC6A3C0OX)  
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71020-100-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/03/2020
2NDC:71020-100-641900 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/03/2020
Labeler - Sante Manufacturing Inc (242048747)

Revised: 6/2020
Document Id: a7381c83-d8a6-404d-e053-2a95a90a909b
Set id: 1c38b650-e5c0-4115-ba7e-78457c0bff2f
Version: 2
Effective Time: 20200603
 
Sante Manufacturing Inc