Label: HANDSOAP- benzalkonium chloride soap

  • NDC Code(s): 51316-703-11, 51316-703-50, 51316-703-56
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 6, 2024

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

  • Purpose

    Antibacterial

  • ACTIVE INGREDIENT

    Benzalkonium Chloride.

  • WARNINGS

    For External Use only

    In case of accidental ingestion, seek medical attention or contact a poison control centre immediately

    ask a doctor ifIrritation or redness develops and lasts

  • DOSAGE & ADMINISTRATION

    Apply onto dry hands. Work into a lather, rinse and dry throughly.

  • STORAGE AND HANDLING

    Store at room temperature

  • INACTIVE INGREDIENT

    Water (aqua), Lauramidopropylamine oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (Cl16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200)

  • INDICATIONS & USAGE

    Helps eliminate bacteria on skin

  • PRINCIPAL DISPLAY PANEL

    56 OZ11.25 OZ

  • INGREDIENTS AND APPEARANCE
    HANDSOAP 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-703
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BASIC YELLOW 5 (UNII: 07BP340B4T)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-703-561660 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2024
    2NDC:51316-703-11333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2024
    3NDC:51316-703-501470 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/01/2021
    Labeler - CVS Pharmacy (062312574)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(51316-703)