ANTIBACTERIAL AQUA CLEAR 2X ULTRA- 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

For external use only

Stop use and ask a doctor if irritation or redness develops

When using this product

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, Blue 1, Red# 4 (Cl 14700)

Uses for handwashing or decrease bacteria to the skin

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ANTIBACTERIAL AQUA CLEAR  2X ULTRA
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71020-030
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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 BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71020-030-641900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2016
2NDC:71020-030-30600 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)
Registrant - Sante Manufacturing Inc (242048747)
Establishment
NameAddressID/FEIBusiness Operations
Sante Manufacturing Inc204348627manufacture(71020-030)
Establishment
NameAddressID/FEIBusiness Operations
Brands International Corporation243748238manufacture(71020-030)

Revised: 1/2022
Document Id: d5d1bcb7-5895-0aee-e053-2a95a90adfeb
Set id: d5d15729-1dc1-2b44-e053-2a95a90a26c5
Version: 2
Effective Time: 20220117
 
Sante Manufacturing Inc