OCEAN MIST SCENTED HAND SANITIZER ANTI-BACTERIAL (BENZETHONIUM CHLORIDE) LIQUID [ENCHANTE ACCESSORIES INC. ]

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OCEAN MIST SCENTED HAND SANITIZER ANTI-BACTERIAL (BENZETHONIUM CHLORIDE) LIQUID [ENCHANTE ACCESSORIES INC. ]
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NDC 50563-109-01
Set ID bb96be36-09c4-4ed4-af37-4cd59dbda3d9
Category HUMAN OTC DRUG LABEL
Packager ENCHANTE ACCESSORIES INC.
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 that could cause diseases

    Recommended for repeated use

  • WARNINGS

    For external use only

    Flammable

    When using this product: Keep out of eyes. In case of contact with eyes, flush thoroughly with water.  Avoid Contact with broken skin. Do not inhale or 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. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands thoroughly with product and allow to dry without wiping
    • For children under 6, use only under adult supervision
    • Not recommended for infants
  • STORAGE AND HANDLING

    Other Information:

    • Do not store above 105F
    • May discolor some fabrics
    • Harmful to wood finishes and plastics
  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Alcohol, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Tocopheryl Acetate, may contain D and C Red No. 33, D 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
    OCEAN MIST SCENTED HAND SANITIZER ANTI-BACTERIAL 
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-109
    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)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-109-01236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/18/2012
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Aidi Cosmetics Co., Ltd.530876820manufacture
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