Label: ANTIBACTERIAL VANILLA AND SHEA BUTTER- benzalkonium chloride liquid

  • NDC Code(s): 50157-508-10, 50157-508-23, 50157-508-37, 50157-508-44
  • Packager: Brands International 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 September 14, 2020

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride - 0.13%

  • PURPOSE

    Purpose - Antiseptic Skin cleanser

  • INDICATIONS & USAGE

    Uses for handwashing or decrease bacteria to the skin

  • WARNINGS

    Warnings For external use only

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops

  • WHEN USING

    When using this product

    • do not get it 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
    • For occasional and personal domestic use
    • Supervise children when they use this product.
  • INACTIVE INGREDIENT

    Lauramidopropylamine oxide, lauryl glucoside, PEG-150 distearate, glycol stearate, perfume, PEG-7 glycerly cocoate, centrimonium chloride, Citric Acid, Glycerin, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone,

  • PRINCIPAL DISPLAY PANEL

    213soap1

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL  VANILLA AND SHEA BUTTER
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-508
    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
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-508-23236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/10/2020
    2NDC:50157-508-373780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/10/2020
    3NDC:50157-508-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/10/2020
    4NDC:50157-508-44443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/10/2020
    Labeler - Brands International Corporation (243748238)
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