Label: TOPCARE ANTIBACTERIAL HAND LIGHT MOISTURIZERS- benzalkonium chloride soap

  • 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 December 27, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Use

    for hand washing, reduces germs on skin

  • Warnings

    For external use only–hands only

    When using this product

    • avoid contact with eyes. If case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develops.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wash hands and rinse.
  • Inactive Ingredients

    Water, Myristyl Amidopropyl Amine Oxide, Cetrimonium Chloride, Glycerin, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Citric Acid, Fragrance, Benzalkonium Chloride, Methylchloroisothiazolinone, Tetrasodium EDTA, D&C Red 33, FD&C Red 40, FD&C Yellow 5

  • Questions?

    Call 1-888-423-0139

  • Other information

    store at 20°C - 25°C (68°F - 77°F)

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007

  • PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label

    TopCare
    everyday ™

    antibacterial
    hand soap
    with light moisturizer

    gently cleans & protects

    COMPARE
    TO SOFTSOAP ®
    ANTIBACTERIAL
    HAND SOAP WITH
    MOISTURIZERS*

    fresh
    & clean

    7.5 FL OZ (221 mL)

    PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    TOPCARE ANTIBACTERIAL HAND LIGHT MOISTURIZERS 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20890-0040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2.34 mg  in 1.8 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20890-0040-1221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/15/2015
    Labeler - Abaco Partners LLC DBA Surefil (964809417)
    Establishment
    NameAddressID/FEIBusiness Operations
    Abaco Partners LLC DBA Surefil964809417manufacture(20890-0040)
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