VANILLA HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [SHENZHEN LANTERN SCIENCE CO., LTD.]

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VANILLA HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [SHENZHEN LANTERN SCIENCE CO., LTD.]
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NDC 54860-089-01
Set ID 64914c6a-aea3-3c30-e053-2a91aa0a88b0
Category HUMAN OTC DRUG LABEL
Packager Shenzhen Lantern Science Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART333E
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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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