NANOCDB- none solution/ drops

NanoCDB by

Drug Labeling and Warnings

NanoCDB by is a Otc medication manufactured, distributed, or labeled by Creative Essences Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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.

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.

How to take NanoCBD (page 1 Leaflet)

PDP

See Final NanoCBD AUS 30mL Label Image.

INGREDIENTS AND APPEARANCE

NANOCDB 
none solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70658-122
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CANNABIDIOL (UNII: 19GBJ60SN5) (CANNABIDIOL - UNII:19GBJ60SN5)	CANNABIDIOL	1.938 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70658-122-12	1 in 1 CARTON	04/21/2020
1		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		04/21/2020

Labeler - Creative Essences Inc (079120182)

Registrant - Creative Essences Inc (079120182)

Establishment
Name	Address	ID/FEI	Business Operations
Creative Essences Inc		079120182	manufacture(70658-122)