Label: OPTISOURCE ANTIBACTERIAL FOAM HAND- benzalkonium chloride soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 4, 2019

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  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

    Uses

    • For hand washing to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings

    For external use only

  • When using

    this product avoid contact with eyes. In case of eye contact, flush eyes with water.

  • Stop using and ask doctor if

    irritation or redness develops, or if condition persists for more than 72 hours.

  • Keep out of reach of children.

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

  • Directions

    • Pump a small amount of foam into palm of hand
    • Rub thoroughly over all surfaces of both hands for 15 seconds
    • Rinse with potable water
  • INACTIVE INGREDIENT

    Inactive Ingredients Water/Agua/Eau, Coco-glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric acid

  • PRINCIPAL DISPLAY PANEL

    12504 Label

  • INGREDIENTS AND APPEARANCE
    OPTISOURCE ANTIBACTERIAL FOAM HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64646-001
    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
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64646-001-024 in 1 CASE12/22/2015
    11250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/03/2015
    Labeler - Charlotte Products Ltd. (248293359)
    Registrant - Charlotte Products Ltd. (248293359)
    Establishment
    NameAddressID/FEIBusiness Operations
    Charlotte Products Ltd.248293359manufacture(64646-001)
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