Label: TOPCARE AMBER ANTIBACTERIAL HAND- 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 contact occurs, 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.
  • Other information

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

  • Inactive Ingredients

    Purified Water, Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Fragrance, Citric Acid, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Red #4, FD&C Yellow #5.

  • QUESTIONS?

    1-888-423-0139

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007

  • PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label

    TopCare®

    TRICLOSAN FREE

    ANTIBACTERIAL

    hand
    soap

    AMBER

    7.5 FL OZ
    (221 mL)

    PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    TOPCARE AMBER ANTIBACTERIAL HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20890-0050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 mg  in 10 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. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20890-0050-1221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/15/2014
    2NDC:20890-0050-21180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/201407/08/2019
    3NDC:20890-0050-31650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/15/2014
    Labeler - Abaco Partners LLC DBA Surefil (964809417)
    Establishment
    NameAddressID/FEIBusiness Operations
    Abaco Partners LLC DBA Surefil964809417manufacture(20890-0050)
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