Label: SPASOAP ANTIBACTERIAL- benzalkonium chloride liquid

  • NDC Code(s): 64855-005-50, 64855-005-60, 64855-005-94
  • Packager: Right Solutions Corporation, The
  • 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 May 19, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Benzalkonium Chloride - 0.13%

  • PURPOSE

    Purpose - Antibacterial

  • INDICATIONS & USAGE

    Uses for handwashing or decrease bacteria to the skin

  • WARNINGS

    For external use only

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops

  • WHEN USING

    When using the product

    • do not get into eyes. If contact occurs, rinse eye thoroughly with water
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • DOSAGE & ADMINISTRATION

    Directions

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

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

  • PRINCIPAL DISPLAY PANEL

    spa soap liquid6001632

  • INGREDIENTS AND APPEARANCE
    SPASOAP  ANTIBACTERIAL
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64855-005
    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-3 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:64855-005-50500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/202008/15/2022
    2NDC:64855-005-60600 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/202008/15/2022
    3NDC:64855-005-94947 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/202008/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/202008/15/2022
    Labeler - Right Solutions Corporation, The (203855150)
    Establishment
    NameAddressID/FEIBusiness Operations
    Right Solutions Corporation, The203855150manufacture(64855-005)