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

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VANILLA GERM KILLA HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [SHENZHEN LANTERN SCIENCE CO., LTD.]
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NDC 54860-080-01
Set ID 4b461328-1079-15a1-e054-00144ff8d46c
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

  • PURPOSE

    Use

    To decrease bacteria on the skin that could cause disease.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS

    Warnings

    • for external use only-hands.
    • keep out of eyes. avoid contact with broken skin.
    • stop use and ask a Doctor if irritation or redness develops.
    • do not inhale or ingest. 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/eau), glycerin, coceth-7, PPG-1-PEG-9 lauryl glycol ether, carbomer, hydrogenated castor oil, fragrance (parfum).

    May Contain

    Red 40 (CI 16035), Red 33 (CI 17200), Blue 1 (CI 42090), Yellow 5 (CI 19140).

  • INDICATIONS & USAGE

    Hand Sanitizer

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    VANILLA GERM KILLA HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYL FRAGMENT (UNII: 0KIZ9B76US)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Colorblue, yellow, redScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54860-080-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/17/2017
    Labeler - Shenzhen Lantern Science Co., Ltd. (421222423)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co., Ltd.421222423manufacture(54860-080)
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