FDA.reportPublic FDA data

NanoCDB

Manufacturer
Creative Essences Inc
Effective date
2020-04-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:15

Label at a glance#

ProductNanoCDB
Active ingredientCANNABIDIOL
Label structure9 sections

Dosage and administration

Active Ingredient (per 2 sprays - 300 microlitres) Cannabidiol (CBD) 5 mg Directions for use: Take as prescribed by your doctor.

Label contents#

Full prescribing information#

Warning Section (Carton AU)

WARNINGS AND PRECAUTIONS SECTION

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 SectionCarton Warning Section

Carton Food Safety Warning

FOOD SAFETY WARNING SECTION

Contains animicrobial preservatives (potassium sorbate).

Indication for Use:

INDICATIONS & USAGE SECTION

As prescribed by health professionals.

Other Safety Information on Cartons (AU)

OTHER SAFETY INFORMATION

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)

INACTIVE INGREDIENT SECTION

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

Section 8 of Leaflet

DESCRIPTION SECTION

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 LeafletProduct Description on Leaflet

Dosage and Administration on Product Label

DOSAGE & ADMINISTRATION SECTION

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 DirectionsLabel Proof showing Active Ingredient and Directions

How to take NanoCBD (page 1 Leaflet)

DOSAGE & ADMINISTRATION SECTION

Section 4. How to take NanoCBDSection 4. How to take NanoCBD

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label ProofLabel ProofSee Final NanoCBD AUS 30mL Label Image.

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CANNABIDIOL Pharmacologic Class Indexing1Indexing - Pharmacologic Class20210608

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70658-122-122022-01-28C16284748780-1d6a99b39-3c43-a426-e053-dadaa90af4c2NanoCBD

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70658-122-12NanoCDB30 mL in 1 BOTTLE, SPRAYSOLUTION/ DROPS301
70658-122-12NanoCDB1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70658-122NANOCDB (NONE) SOLUTION/ DROPS [CREATIVE ESSENCES INC]12 package rows20200428_a3d95773-5f37-4f79-e053-2a95a90a131d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70658-12270658-122-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
CANNABIDIOL19GBJ60SN5ACTIB
POTASSIUM SORBATE1VPU26JZZ4IACT
REBAUDIOSIDE AB3FUD0528FIACT
PEPPERMINT OILAV092KU4JHIACT
POLYOXYL 40 CASTOR OIL4ERD2076EFIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a3d95773-5f38-4f79-e053-2a95a90a131da3d95773-5f37-4f79-e053-2a95a90a131d2020-04-21WarningsExact identifier
spl id: a3d95773-5f38-4f79-e053-2a95a90a131d
spl set id: a3d95773-5f37-4f79-e053-2a95a90a131d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.