Label: NANOCDB- none solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated April 21, 2020

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  • Warning Section (Carton AU)

    Medication may cause drowsiness. Do not drive a vehicle or operate machinery. Do not overdose - avoid alcohol. If an overdoes is taken see your health professional. If in doubt, contact a Poisons Information Centre (13 11 26) or a doctor.

    Carton Warning Section

  • Carton Food Safety Warning

    Contains animicrobial preservatives (potassium sorbate).

  • Indication for Use:

    As prescribed by health professionals.

  • Active ingredients and direction (Carton AU)

  • Other Safety Information on Cartons (AU)

    Store below 25C away from light. Keep out of reach of children. Tamper Evident. Do not use if safety seals are broken.

  • Inactive Ingredients on Leaflet (Page 2)

    Water, modified vegetable oil, glycerol, citric acid, potassium sorbate, sucralose, peppermint oil

  • Section 8 of Leaflet

    What is looks like

    NanoCBD is provided as a dark-amber liquid in a while 30 mL plastic spray container and a pump. The pump is protected with a plastic cup. NanoCelle is a novel drug delivery system that enables very small particles to be delivered as an oral spray. The Nanocelle spray contains submicron size particles with a fat-soluble core containing the drug, and a water-soluble outer layer.

    NanoCBD is a mouth spray (oro-buccal spray) wihch contains the active ingredient cannacidiol. Product Description on Leaflet

  • Dosage and Administration on Product Label

    Active Ingredient (per 2 sprays - 300 microlitres) Cannabidiol (CBD) 5 mg

    Directions for use: Take as prescribed by your doctor.

    Label Proof showing Active Ingredient and Directions

  • How to take NanoCBD (page 1 Leaflet)

    Section 4. How to take NanoCBD

  • PDP

    Label ProofSee Final NanoCBD AUS 30mL Label Image.

  • INGREDIENTS AND APPEARANCE
    NANOCDB 
    none solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70658-122
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANNABIDIOL (UNII: 19GBJ60SN5) (CANNABIDIOL - UNII:19GBJ60SN5) CANNABIDIOL1.938 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 77.27 g  in 100 mL
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.096 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 4.41 g  in 100 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.1 g  in 100 mL
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    PEPPERMINT OIL (UNII: AV092KU4JH) 0.31 g  in 100 mL
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) 15.65 g  in 100 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70658-122-121 in 1 CARTON04/21/2020
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only04/21/2020
    Labeler - Creative Essences Inc (079120182)
    Registrant - Creative Essences Inc (079120182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creative Essences Inc079120182manufacture(70658-122)
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