Label: FLOWER PELLE BUBBLE ANTIBACTERIAL HAND WASH- benzalkonium chloride liquid

  • 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 22, 2020

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  • Active ingredient

    Benzalkonium Chloride 0.05%

  • Purpose

    Antimicrobial

  • Use

    • For hand sanitizer to decrease bacteria on the skin
  • Warnings

    For external use only

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

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

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

  • Directions

    Pump into hands, wet as needed.
    Lather vigorously for at least 10 seconds.
    Wash hands, rinse thoroughly and dry

  • Inactive ingredients

    Water, Sodium Laureth Sulfate, Glycerin, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Cocamide MIPA, Sodium Chloride, Fragrance, Citric acid, Butylene Glycol, Hexylene glycol, Isopropanolamine, 1,2-Hexanediol, Portulaca Oleracea Extract

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    FLOWER PELLE BUBBLE ANTIBACTERIAL HAND WASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81328-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ISOPROPANOLAMINE (UNII: UE40BY1BZW)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PURSLANE (UNII: M6S840WXG5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81328-001-021 in 1 CARTON12/22/2020
    1NDC:81328-001-01250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/22/2020
    Labeler - F&I (695504442)
    Registrant - F&I (695504442)
    Establishment
    NameAddressID/FEIBusiness Operations
    F&I695504442manufacture(81328-001)
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