Label: NANOCDB- none solution/ drops

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 21, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!