Drug Labeling and Warnings

Drug Details

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ANTIBACTERIAL- benzalkonium chloride liquid 
Brands International Corporation

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

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

  • do not get 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

Directions

  • Wet Hands
  • Apply palmful to hands
  • Scrub thoroughly
  • Rinse

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

Antibacterial Liquid Soap

ANTIBACTERIAL 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50157-001
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: 50157-001-16500 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 - Brands International Corporation (243748238)
Registrant - Sante Manufacturing Inc (242048747)
Establishment
NameAddressID/FEIBusiness Operations
Brands International Corporation243748238manufacture(50157-001)

Revised: 3/2018
 
Brands International Corporation


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