Product Description #40-50

Description: Broad-Spectrum CBD oil (40%, 50%) with piperine

 Description
What Is It?– Extracts derived from hemp plants, safe, non-addictive, and have no set dosage limit.
 – They contain cannabidiol (CBD). CBD is scientifically proven that can help with a range of health issues.
Natura-Remedy Series

– We offer ultra-strong CBD oils (40%, 50%).

Please Note: Natura-Remedy CBD oils are very concentrated and might crystallize under 25 degrees Celcius. If crystallization occurs, please follow the ben marie instructions provided in the table below. Crystallization is a sign of good quality and potency.

Possible Supplemental Applications– Although these products are not medicines, CBD looks promising for various conditions according to existing bibliography, for panic 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: Take them under professional guidance if you have any health concerns.
 – Results can vary: Consult your physician for personalized advice. 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

The products in this collection are available in a crystallized liquid form. If crystallization occurs, please apply heat to ensure optimal consistency following these steps:

·        Carefully place the bottle in boiling water covering only the glass part of the bottle. Make sure the bottle is sealed well, preventing any water into the bottle.

·        Leave it in the water for approximately 3 minutes.

·        Remove the bottle from the water, ensuring to handle it with care.

Storing conditions

To be stored at temperatures between 22°C to 30°C, in a dry, dark and cool environment. Lower temperatures might cause crystallization.

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

For optimal results, it is recommended to administer 2-5 drops, 1-2 times per day. Ideally, this should be done in front of a mirror, half an hour before dinner and/or 10 minutes before bedtime. However, if the product is being used as a supplemental treatment for a specific disease, it is strongly advised to follow the guidelines provided by a healthcare professional. This ensures safe and effective use tailored to your specific health needs.

Heavy metal check

DIN EN 13657: 2003-01 

CPNP European registration number for oral care

40% with piperine: 4470963

50% with piperine: 4470964

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 (40%, 50%) 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

  • Natura-Remedy Series:
    • Ultra-strong CBD oils (40%, 50%) for those seeking high-potency products.
    • Suitable for various applications including sleep enhancement, deep relaxation, and pain management.
  • 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 40% and 50% CBD concentrations.

  • Physical/Chemical Characteristics and Stability:

    • Store at 22°C to 30°C in a dry, dark, and cool environment. Lower temperatures may cause crystallization. If crystallization occurs, it can be liquified using a Ben-Marie method.
    • 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, 1-2 times daily, ideally half an hour before dinner and/or 10 minutes before bedtime.

Part B: Safety Assessment

Prepared by: Charalambos Georgiou, Chemical Engineer

  • Safety Assessment for Broad-Spectrum CBD Oil with Piperine
    The CBD oil and piperine extracts are produced using a cold ethanol extraction method, ensuring high purity and preservation of bioactive compounds. Both the cannabis and pepper extracts are manufactured in a c-GMP compliant facility, adhering to strict Good Manufacturing Practices. Carrier oils used in this formulation are obtained through cold pressing and meet ISO 22000 and ISO 9001 standards, guaranteeing their quality, stability, and safety. All materials used are food and cosmetic grade certified.

  • Manufacturing Process and Quality Control
    The final product formulation occurs on a small scale under controlled conditions. The formulation process involves a closed-loop heating mantle and a liquid filling machine, both of which are sterilized with grain alcohol prior to each production cycle. Access to the laboratory is restricted to the Chemical Engineer, who utilizes specialized safety uniforms to ensure a contaminant-free environment. The laboratory itself is maintained to the highest hygiene standards, being cleaned daily using isopropyl alcohol on the surfaces, grain alcohol on the glassware and robotic vacuum cleaner for vacuum cleaning and mopping.

  • Storage Conditions
    All finished products, along with raw materials, are stored in a shared environment designed to prevent exposure to humidity and sunlight. This storage space is consistently kept clean, ensuring the long-term stability and safety of the products.

  • Safety Profile and Precautions
    Extensive literature indicates that CBD is non-lethal and lacks significant adverse effects, even at high doses. Unlike THC, CBD does not impact the brainstem, thus avoiding risks to vital functions such as heart rate and breathing. However, while the product is generally well-tolerated, some users may experience minor side effects if exceeding the recommended dosage. These potential side effects include dry mouth, nausea, drowsiness, changes in appetite, vomiting, and mild gastrointestinal discomfort.

    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 Natura-Remedy 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., 40% (4000 mg), 50% (5000 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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