Product Description #3-5-10-15
Description: Broad-Spectrum CBD oil (3%, 5%, 10%, 15%) with piperine
| Description | |
|---|---|
| What Is It? | – Extract derived from hemp plants (Cannabis sativa). Contains phytocannabinoids, terpenes, and bioactive compounds. Non-psychotropic (unlike THC). They’re not addictive and there’s no set limit on how much you can use. |
| Phyto-Relax Series | – 3% and 5%: Suitable for beginners. Promotes general wellness and relaxation. – 10% and 15%: Advanced options for personalized dosing based on individual needs. – Specifically designed for athletes and overall well-being. – Promotes relaxation, concentration, and mood enhancement. – Beneficial for combat sports and weight lifting recovery. |
| Piperine Enhancement | – Contains piperine from black pepper. Enhances CBD absorption. |
| Possible Supplemental Applications | – Although these products are not medicines, cannabidiol (CBD) looks promising for various conditions according to existing bibliography, for anxiety disorders, sleep problems, multiple sclerosis, side effects from cancer medication, asthma, diabetes, depression, high blood pressure, psoriasis, osteoporosis, autism, glaucoma, Crohn’s disease, anorexia, seizures, schizophrenia, chronic pain, heart problems, and immune system support. However, further research is required and results can vary. |
| Important Notice | – Medical Supervision: High doses should be administered under professional guidance. Consult your physician for personalized recommendations. |
| – Health Priority: Always prioritize your well-being. These products are not intended to diagnose, cure, or prevent any disease. |
Active Ingredients: Cannabidiol
CAS No.: 13956-29-1
ECHA No.: 689-176-3
Molecular type: C21H30O2
Molecular weight: 314,46 g/mol
General Information
Administration method | Sublingual administration. Sublingual administration involves placing the oil under the tongue for 3-5 minutes. It is recommended to look upwards as you place it to allow the oil to spread underneath the tongue. Make sure you haven’t consumed any liquids or solid foods at least 10 minutes before the procedure. |
Content | CBD oil is liquid at atmospheric temperature. |
Storing conditions | To be stored at temperatures between 15°C to 25°C, in a dry, dark and cool environment. |
Shelf-life | Up to 3 years from the production date. If opened, it should be used within 12 months. |
Packaging | 10 ml dark-colored glass bottle. |
Dosing pipette | Glass pipette approved by Commission Regulation (EU) no. 10/2011. |
Recommended dose | It is recommended to use 2-5 drops (in front of the mirror) 2 times per day. It is advised to do it half an hour after breakfast and 10 minutes before training or studying. |
Heavy metal check | DIN EN 13657: 2003-01 |
CPNP European registration number for oral care | 3% with piperine: 4588722 5% with piperine: 4470957 10% with piperine: 4470959 15% with piperine: 4470960 |
Suitable for Vegans | Yes |
Precautions | CBD oil is generally considered safe for most users, but it may cause side effects such as drowsiness, dry mouth, diarrhea, decreased appetite, nausea, vomiting, mood changes, and alterations in blood pressure and heart rate. More serious and rare side effects may include allergic reactions. CBD oil can also interact with certain medications, including antiepileptic drugs, antidepressants, antipsychotics, anticoagulants, opioids, benzodiazepines, steroids, and NSAIDs.
This product is not recommended for pregnant or breastfeeding women and newborns. |
Certificates Of Analysis
Our products undergo rigorous quality control checks, and we obtain certificates of analysis for cannabinoids, heavy metals, pesticides, and any residual solvents.
Product Information File (PIF)
1. Product Description
- Product Name: Broad-Spectrum CBD Oil (3%, 5%, 10%, 15%) with Piperine
- Description: A sublingual CBD oil designed as an oral care cosmetic product. Contains phytocannabinoids, terpenes, piperine to enhance CBD absorption, and vitamin E-rich sunflower oil as an antioxidant.
- Intended Use: Oral care; applied sublingually.
- Physical Form: Liquid, housed in a 10 ml dark-colored glass bottle with a dosing pipette.
- Packaging: Glass bottle approved by Commission Regulation (EU) no. 10/2011, equipped with a dosing pipette.
2. Product Claims
- 3% and 5%: Suitable for beginners. Promotes general wellness and relaxation.
- 10% and 15%: Advanced options for personalized dosing based on individual needs.
- Athletic Use: Specifically designed for athletes and overall well-being.
- Promotes relaxation, concentration, and mood enhancement.
- Beneficial for recovery from combat sports and weight lifting.
- Supporting Scientific Evidence:
- Boychuk DG, et al. (2015). The effectiveness of cannabinoids in the management of chronic nonmalignant neuropathic pain: a systematic review. Journal of Oral & Facial Pain and Headache, 29(1), 7-14.
- Russo EB. (2008). Cannabinoids in the management of difficult to treat pain. Therapeutics and Clinical Risk Management, 4(1), 245-259.
- Nagarkatti P, et al. (2009). Cannabinoids as novel anti-inflammatory drugs. Future Medicinal Chemistry, 1(7), 1333-1349.
- Zurier RB, et al. (2016). Cannabinoids, inflammation, and fibrosis. The FASEB Journal, 30(11), 3682-3689.
- Crippa JA, et al. (2011). Neural basis of anxiolytic effects of cannabidiol (CBD) in generalized social anxiety disorder: a preliminary report. Journal of Psychopharmacology, 25(1), 121-130.
- Blessing EM, et al. (2015). Cannabidiol as a potential treatment for anxiety disorders. Neurotherapeutics, 12(4), 825-836.
- Babson KA, et al. (2017). Cannabis, cannabinoids, and sleep: a review of the literature. Current Psychiatry Reports, 19(4), 23.
- Linares IM, et al. (2019). Cannabidiol presents an inverted U-shaped dose-response curve in a simulated public speaking test. Brazilian Journal of Psychiatry, 41(1), 9-14.
3. Product Safety Report (CPSR)
Part A: Safety Information
Quantitative and Qualitative Composition:
- INCI Ingredients:
- Helianthus Annuus Seed Oil
- Caprylic/Capric Triglyceride
- Cannabidiol (CBD) – Derived from extract or tincture or resin of cannabis
- Piper Nigrum Seed Extract
- Available in 3%, 5%, 10%, and 15% CBD concentrations.
- INCI Ingredients:
Physical/Chemical Characteristics and Stability:
- Store at 15°C to 25°C in a dry, dark, and cool environment.
- Shelf life: Up to 3 years unopened; use within 12 months after opening.
Microbiological Quality: Complies with microbiological quality standards for oils.
Impurities, Traces, and Packaging:
- Glass bottle packaging, compliant with EU standards.
- Heavy metal check performed under DIN EN 13657:2003-01 standards.
Normal and Reasonably Foreseeable Use:
- Administration: Sublingual application by placing oil under the tongue for 3-5 minutes.
Exposure to the Cosmetic Product:
- Recommended dosage: 2-5 drops under the tongue, twice per day, after breakfast and before training or studying.
Toxicological Profile:
According to available scientific evidence, CBD is not lethal and does not cause a fatal overdose. CBD lacks significant effects on the brainstem, making it much safer than substances like opioids, which can impact breathing and heart rate. Although generally safe, CBD may cause side effects, including dry mouth, drowsiness, nausea, diarrhea, and appetite changes. Users are advised to follow recommended dosages responsibly and consult a physician if taking other medications.
Part B: Safety Assessment
Prepared by: Charalambos Georgiou, Chemical Engineer
The safety assessment confirms that the product is generally safe, even in larger doses. However, adherence to recommended usage guidelines is advised.
Manufacturing Process and Quality Control:
The CBD oil and piperine extracts are produced using cold ethanol extraction in a c-GMP compliant facility. Carrier oils are cold-pressed to meet ISO 22000 and ISO 9001 standards, and all materials used are certified for food and cosmetic grade.
The final product is formulated on a small scale under controlled conditions, using sterilized equipment and a clean laboratory maintained daily with isopropyl and grain alcohol for sanitizing surfaces and glassware, respectively.
Storage Conditions:
All finished products and raw materials are stored in a shared environment, away from humidity and sunlight.
Safety Profile and Precautions:
CBD may cause rare allergic reactions, such as rash, itching, or difficulty breathing. It can also interfere with liver enzymes (cytochrome P450), affecting certain medications (e.g., antiepileptics, antidepressants, opioids). Consult a healthcare provider before use if taking these medications, and monitor liver function for prolonged use.
Conclusion:
The Broad-Spectrum CBD Oil with Piperine meets strict regulatory and quality control standards. It is safe for general use, but users should follow guidelines and consult healthcare providers if on other medications.
4. Proof of Effect
- Scientific References:
- Bergamaschi MM et al. Safety and side effects of cannabidiol: A review of clinical data and relevant animal studies. Current Drug Safety, 2017; 12(2): 81-90.
- Verywell Health: CBD Oil Benefits, Uses, and Side Effects
- Harvard Health: CBD and Other Medications – Proceed with Caution
- Mayo Clinic: CBD – Safe and Effective?
- FDA: What to Know About Products Containing Cannabis and CBD
5. Labeling
- Label Includes:
- Product name and concentration (e.g., 3% (300 mg), 5% (500 mg), 10% (1000 mg), 15% (1500 mg))
- Full ingredient list in INCI format
- CPNP registration number for each concentration
- Usage instructions, dosage recommendations, and precautions
- Manufacturer details and batch number
- Net contents (10 ml)
- Storage conditions and shelf-life
- Vegan and other specific labels as applicable
6. Data on Animal Testing
- No animal testing was conducted on the final product or ingredients, in compliance with EU cosmetic regulations.
This Product Information File (PIF) is intended for regulatory authorities to ensure the Broad-Spectrum CBD Oil with Piperine meets compliance and safety standards.