Label: BETTER LIVING BRANDS- benzalkonium chloride soap

  • NDC Code(s): 21130-048-11, 21130-048-50
  • Packager: Better Living Brands LLC
  • 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 February 8, 2023

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  • ACTIVE INGREDIENT

    Benzalkonium chloride 0.13%

  • PURPOSE

    Antibacterial

  • INDICATIONS & USAGE

    helps eliminate bacteria on hands

  • WARNINGS

    For external use only

    Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Ask a doctor

    if irritation or redness develops and lasts

    incase of accidental ingestion, seek medical attention or contact a poison control centre immediately.

  • Directions

    • Apply onto wet hands.
    • lather and rinse thoroughly
  • STORAGE AND HANDLING

    Store at room temperature

  • INACTIVE INGREDIENT

    Water, Lauramidopropylamine oxide, Glycerin, Cetrimonium Chloride, Sodium chloride, Cocamide MEA , PEG-120 Methyl Glucose Dioleate, fragrance, Citric Acid , Tetrasodium EDTA, Sodium sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40, Yellow 5, Red 33

  • QUESTIONS

    1-888-723-3929

  • PRINCIPAL DISPLAY PANEL

    50 oz11.25 oz

  • INGREDIENTS AND APPEARANCE
    BETTER LIVING BRANDS 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE130 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    COCAMIDE (UNII: 3YXD33R71G)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BASIC YELLOW 5 (UNII: 07BP340B4T)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-048-11333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
    2NDC:21130-048-501479 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/08/2023
    Labeler - Better Living Brands LLC (009137209)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(21130-048)
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