ANTIBACTERIAL  2X- 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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Benzalkonium Chloride - 0.13%

Purpose: Antibacterial

Direction

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse

For external use only

Stop use and ask a doctor if irritation or redness develops

When using this product

  • do not get it into eyes. If contact occurs, rinse eye thoroughly with water

Keep out of reach of children

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

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

Uses for handwashing or decrease bacteria to the skin

16-16

2X

ANTIBACTERIAL   2X
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71020-016
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
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
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:71020-016-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/30/2018
Labeler - Sante Manufacturing Inc (242048747)
Registrant - Sante Manufacturing Inc (242048747)
Establishment
NameAddressID/FEIBusiness Operations
Brands International Corporation243748238manufacture(71020-016) , label(71020-016)

Revised: 8/2021
Document Id: ca186e49-5190-789e-e053-2a95a90a2236
Set id: 00179db3-5a76-4724-a848-28e71eb580a6
Version: 4
Effective Time: 20210821
 
Sante Manufacturing Inc