Label: TOPCARE ANTIBACTERIAL BERRY BLAST FOAMING 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

  • Uses

    for handwashing, reduces germs on the skin

  • Warnings

    For external use only–hands only

    When using this product

    • Avoid contact with eyes. In 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

    • Pump into to dry hands, vigorously work into a lather and rinse thoroughly.
  • Inactive ingredients

    Purified Water, Lauramine Oxide, Glycerin, Cocamidopropyl Betaine, Isostearamidopropyl Ethyldimonium Ethosulfate, Fragrance, DMDM Hydantoin, Tetrasodium EDTA, Hydroxypropyl Methyl Cellulose, Chlorhexidine Gluconate, Zinc Sulfate Monohydrate, Citric Acid, FD&C Red #33 (CI17200), FD&C Orange #4 (CI15510)

  • Other information

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

  • Questions?

    Call 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 ®

    ANTIBACTERIAL
    foaming
    hand soap

    gentle enough
    for every day

    BERRY BLAST

    7.5 FL OZ (221 mL)

    Principal Display Panel - 221 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    TOPCARE ANTIBACTERIAL BERRY BLAST FOAMING HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20890-0100
    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)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ISOSTEARAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATE (UNII: U059JNZ17L)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    ZINC SULFATE MONOHYDRATE (UNII: PTX099XSF1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20890-0100-1221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2016
    Labeler - Abaco Partners LLC DBA Surefil (964809417)
    Establishment
    NameAddressID/FEIBusiness Operations
    Abaco Partners LLC DBA Surefil964809417manufacture(20890-0100)
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