Label: RELIABLE LUXURY FOAM ANTIMICROBIAL HANDWASH CITRUS FLORAL SCENT- benzalkonium chloride liquid

  • NDC Code(s): 71897-401-40, 71897-401-42
  • Packager: Veritiv Operating Company
  • 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 November 16, 2022

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  • Active ingredient

    Benzalkonium Chloride 0.5%

  • Purpose

    Antimicrobial

  • Uses

    • Handwash to help decrease bacteria on the skin

    • Recommended for repeated use

  • Warnings

    For external use only

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts

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

  • Directions

    • Wet hands

    • Apply a small amount of product and work into a lather

    • Rinse well and dry hands completely

  • Inactive Ingredients

    Water (Aqua), Propylene Glycol, Glycerin, Cocamidopropyl Betaine, PEG-80 Sorbitan Laurate, Citric Acid, Ethylhexylglycerin, Lauramine Oxide, Polyquaternium-10, Fragrance (Parfum), Phenoxyethanol, Blue 1 (CI 42090), Red 33 (CI 17200)

  • PRINCIPAL DISPLAY PANEL

    Product LabelProduct Label

  • INGREDIENTS AND APPEARANCE
    RELIABLE LUXURY FOAM ANTIMICROBIAL HANDWASH CITRUS FLORAL SCENT 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71897-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.005 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    PEG-80 Sorbitan Laurate (UNII: 239B50Y732)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Lauramine Oxide (UNII: 4F6FC4MI8W)  
    POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71897-401-401200 mL in 1 PACKAGE; Type 0: Not a Combination Product04/30/2017
    2NDC:71897-401-421250 mL in 1 PACKAGE; Type 0: Not a Combination Product04/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/30/2017
    Labeler - Veritiv Operating Company (006989982)