Product Description #20-25-30

Description: Broad-Spectrum CBD oil (20%, 25%, 30%) 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.
Anti-Stress Series– High concentrations (20%, 25%, 30%) suitable for nighttime use. They can be used for sleep enhancement, deep relaxation, and stress reduction. They might be effective for both chronic pain and muscle pain. Individual results may vary.
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.
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.

For more information, please visit this link which provides scientific information and research about CBD oil. We encourage you to check it out to learn more about our commitment to scientific accuracy.

 

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. High-potency CBD oils (>25%) may crystallize in cold environments due to oversaturation of CBD. To prevent this, store the oil at room temperature. If crystallization occurs, cautiously warm the bottle by placing it in boiling water for 3 minutes.

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 consumed 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 before dinner and 10 minutes before bedtime.

Heavy metal check

DIN EN 13657: 2003-01 

CPNP European registration number for oral care

20% with piperine: 4470961

25% with piperine: 4470962

30% with piperine: 4470920

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.

  • Consult your doctor before using CBD oil, if you are taking other medications.
 
  • Monitor your liver function regularly if you use CBD oil for a prolonged period.
 
  • Seek immediate medical attention if you experience symptoms of an allergic reaction, such as skin rash, itching, swelling, or difficulty breathing.
 

This product is not recommended for pregnant or breastfeeding women and newborns.

Product Information File (PIF)

1. Product Description

  • Product Name: Broad-Spectrum CBD Oil (20%, 25%, 30%) 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

  • Anti-Stress Series:
    • High concentrations (20%, 25%, 30%) suitable for nighttime use.
    • Can be used for sleep enhancement, deep relaxation, and stress reduction.
    • Effective for both chronic pain and muscle pain, although individual results may vary.
  • Supporting Scientific Evidence:
    • Singh K, et al. Emerging Therapeutic Potential of Cannabidiol (CBD) in Neurological Disorders: A Comprehensive Review. Behav Neurol. 2023 Oct 12; 2023:8825358. doi: 10.1155/2023/8825358. PMID: 37868743; PMCID: PMC10586905.

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 20%, 25%, and 30% CBD concentrations.

  • 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, half an hour before dinner and 10 minutes before bedtime.

Part B: Safety Assessment

Prepared by: Charalambos Georgiou, Chemical Engineer

  • Safety Assessment for Broad-Spectrum CBD Oil with Piperine
    This product is produced under stringent quality and safety standards and contains phytocannabinoids, terpenes, piperine for enhanced absorption, and vitamin E-rich sunflower oil as an antioxidant. Based on available scientific data, the product is considered safe when used as directed.

  • 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 meet ISO 22000 and ISO 9001 standards. The final formulation is prepared on a small scale under controlled conditions, using sterilized equipment.

  • Storage Conditions
    All products are stored in a shared environment designed to prevent exposure to humidity and sunlight, maintaining long-term stability.

  • Safety Profile and Precautions
    While the product is generally well-tolerated, users should follow recommended dosages and consult a physician if taking other medications, especially if they experience side effects such as drowsiness, dry mouth, diarrhea, decreased appetite, and nausea. Rare but serious allergic reactions may occur.

    CBD can interfere with liver enzymes (cytochrome P450), which may affect the metabolism of certain medications. Consult a healthcare provider before use if taking medications like:

    • Antiepileptics
    • Antidepressants
    • Antipsychotics
    • Anticoagulants
    • Opioids
    • Benzodiazepines
    • Steroids
    • NSAIDs

Conclusion
The Broad-Spectrum CBD Oil with Piperine Anti-Stress Series is formulated and produced under strict regulatory and quality control conditions. It is safe for general use; however, users are advised to follow usage guidelines and seek medical advice if on other medications.

Signature:
Charalambos Georgiou, Chemical Engineer

4. Proof of Effect

5. Labeling

  • Label Includes:
    • Product name and concentration (e.g., 20% (2000 mg), 25% (2500 mg), 30% (3000 mg)).
    • Full ingredient list in INCI format.
    • CPNP registration number for each concentration.
    • Usage instructions and recommended dosage.
    • Precautionary statements and side effects.
    • 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

  • Compliance: No animal testing was conducted on the final product or ingredients, in compliance with EU cosmetic regulations.
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