VANILLA CUPCAKE ANTI BACTERIAL HAND SANITIZER (BENZETHONIUM CHLORIDE) LIQUID [FIVE BELOW]

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VANILLA CUPCAKE ANTI BACTERIAL HAND SANITIZER (BENZETHONIUM CHLORIDE) LIQUID [FIVE BELOW]
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NDC 59021-011-01
Set ID ff9e476b-2cbf-4500-afc0-17e00213ab92
Category HUMAN OTC DRUG LABEL
Packager Five Below
Generic Name
Product Class
Product Number
Application Number PART333E
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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzethonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    To decrease bacteria on the skin

  • WARNINGS

    For external use only

    When using this product: Keep out of eyes. Do not ingest.


  • ASK DOCTOR

    Stop use and ask a doctor if skin irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical assistance.

  • DOSAGE & ADMINISTRATION

    Directions

    • Rub a dime size drop into hands
  • STORAGE AND HANDLING

    Other Information:

    • Do not store above 105F
    • May discolor some fabrics
  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Deionized Water, Carbomer, Triehtanolamine, PEG-40 Hydrogenated Castor Oil, Fragrance, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

  • PRINCIPAL DISPLAY PANEL

    lablabel

  • INGREDIENTS AND APPEARANCE
    VANILLA CUPCAKE ANTI BACTERIAL HAND SANITIZER  
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59021-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 82 g  in 100 mL
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59021-011-01225 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/12/2013
    Labeler - Five Below (095446659)
    Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Aidi Cosmetics Co., Ltd.530876820manufacture(59021-011)
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