Label: PERSONAL CARE FOAMING HAND SANITIZER- 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 April 12, 2018

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  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antibacterial

  • Uses

    for washing hands to decrease bacteria on the skin

  • Warnings

    For external use only

  • When using this product

    ■ avoid contact with the eyes. In case of eye contact, flush with water.

  • Stop use and ask a doctor if

    ■ irritation or rash develops

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ pump into hands ■ lather vigorously for at least 15 seconds ■ rinse and dry thoroughly.

  • Inactive ingredients

    water (aqua), laureth-9, disodium cocoamphodiacetate, polyquaternium-10, citric acid, fragrance, glycerin, methylchloroisothiazolinone, methylisothiazolinone, FD&C blue no. 1, FD&C yellow no. 5

  • Package Label

    Paackage Label

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE  FOAMING HAND SANITIZER
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLIDOCANOL (UNII: 0AWH8BFG9A)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72133-150-75221.8 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/02/2018
    Labeler - Delta Brands & Products LLC (080999173)
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