Label: VANILLA HAND SANITIZER- benzalkonium chloride gel

  • Category: HUMAN OTC DRUG LABEL

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 February 6, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Antibacterial

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS

    Warnings

    • for external use only
    • if irritation occurs discontinue use
    • keep out of eyes
    • avoid contact with broken skin
    • do not inhale or ingest
    • stop use and ask if doctor if skin irritation develops
    • keep out of reach of children
    • if swallowed, get medical help or contact a poison control center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    • Rub a dime sized drop into hands.
    • For children under 6 use under adult supervision.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    water/aqua, hydroxyethylcellulose, phenoxyethanol, fragrance/parfum, disodium edta

  • INDICATIONS & USAGE

    To decrease bacteria on hands

  • PRINCIPAL DISPLAY PANEL

    label

    label

  • INGREDIENTS AND APPEARANCE
    VANILLA HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-089
    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
    HYDROXYETHYL ETHYLCELLULOSE (UNII: ZDN57Z154K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54860-089-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/30/2018
    Labeler - Shenzhen Lantern Science Co., Ltd. (421222423)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co., Ltd.421222423manufacture(54860-089)
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