Label: INDULGENCE/PROPOWER- benzalkonium chloride soap

  • NDC Code(s): 61307-213-10, 61307-213-41
  • Packager: U S Chemical Corporation
  • 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 August 24, 2023

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13% w/w

  • PURPOSE

    Antibacterial Agent

  • INDICATIONS & USAGE

    For handwashing to decrease bacteria on skin.

  • WARNINGS

    For external use only.

    Avoid contact with eyes. In case of contact, flush with plenty of water.

    Stop use and ask a doctor if irritation or rash appears and persists.

  • 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. ​EMERGENCY TELEPHONE: 1-866-923-4913

  • DOSAGE & ADMINISTRATION

    To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

  • INACTIVE INGREDIENT

    Water, cocamidopropyl betaine, cocamidopropyl PG-dimonium chloride phosphate, PEG-6 cocamide, laurtrimonium chloride, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), fragrance, iodopropynyl butylcarbamate, methylisothiazolinone, yellow 5, red 33.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    INDULGENCE/PROPOWER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61307-213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2.5 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61307-213-411 L in 1 BAG; Type 0: Not a Combination Product01/30/2017
    2NDC:61307-213-101 L in 1 BAG; Type 0: Not a Combination Product01/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/30/2017
    Labeler - U S Chemical Corporation (031457842)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(61307-213)
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