Label: BROOKSTONE LEMON ZEST ADVANCED FOAMING HAND SANITIZER- benzalkonium chloride solution

  • 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 17, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose: 

    Antibacterial

  • Use

    Decreases bacteria on skin that could cause diseases

    Recommended for repeated use

  • Warnings

    For external use on hands only.

  • When using this product

    When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water

    Do not ingest or inhale

    Avoid contact with broken skin

  • Stop use and ask a doctor

    if irrigation and redness develop or if condition persists for more than 72 hours

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    • Spread product on hands thoroughly and allow to dry, do not wipe off
    • For children under 6, use only under adult supervision
    • Not recommended for use with infants
  • Other information

    Do not store above 105F (40.6C)

    May discolor some fabrics

    Harmful to plastics and wood finished

  • Inactive ingredients

    Water, Sodium lauroamphoacetate, Cocamidopropylamine oxide, Cocamidopropyl betaine, Glycerin, Olea europaea (olive) leaf extract, Polyminopropyl biguanide, Citric acid, Disodium EDTA, Benzophenone-3, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Cetylpyridinium chloride, Yellow 5 (CI19140)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BROOKSTONE LEMON ZEST ADVANCED FOAMING HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77731-087
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DISODIUM HEDTA (UNII: KME849MC7A)  
    BENZOPHENONE (UNII: 701M4TTV9O)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77731-087-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/17/2020
    Labeler - Argento sc by sicura inc. (168718778)
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