Product Name: Hemp Hot Cream 500mg CBD with Piperine and Capsaicin
Description: Hemp Hot Cream combines CBD, capsaicin, and piperine with nourishing oils, designed to provide relief for muscles and joints, aid in recovery, and offer soothing comfort. The product utilizes beeswax as a protective agent. All key ingredients are manufactured under GMP-compliant processes to ensure quality and effectiveness.
Intended Use: Topical skincare product for specific areas of discomfort; not for use on the face, wounds, or sensitive areas.
Physical Form: Soft beeswax-based cream with a warming effect from capsaicin, packaged in a 40 ml transparent glass jar.
CPNP Registration Number: 4678406

1. Ingredients (INCI)

• Cannabidiol (derived from extract or tincture or resin of cannabis)
• Olea Europaea (Olive) Fruit Oil
• Helianthus Annuus (Sunflower) Seed Oil
• Cera Alba (Beeswax) – Pharma Grade, registered with EOF
• Piper Nigrum (Black Pepper) Seed Extract
• Capsaicin – Produced in a GMP-certified facility

2. Product Claims and Efficacy

• Pain Relief: Contains CBD, which interacts with the endocannabinoid system and may reduce inflammation and discomfort. The warming effect of capsaicin enhances relief for targeted discomfort.
• Muscle Recovery: Combines CBD, sunflower oil, and olive oil to support muscle repair and recovery, particularly post-exercise. Capsaicin’s warming properties provide relief for sore areas.
• Arthritis Support: Regular use promotes flexibility, reduces soreness, and may alleviate symptoms associated with arthritis.
• Period Pain Relief: When applied to the abdomen, the cream provides warmth and comfort, potentially easing menstrual cramps.

Capsaicin’s warming properties help alleviate aches, and piperine, derived from black pepper, optimizes the bioavailability of active ingredients. This product is formulated to deliver maximum efficacy through a natural, carefully balanced composition.

3. Usage Instructions

• Application: Apply a small amount to clean, dry skin, massaging until absorbed. Ideal for muscles, joints, and abdomen.
• Restrictions: Avoid facial use, wounds, and sensitive body areas.
• Frequency: Use as needed, following recommended application instructions.

4. Product Safety Report (CPSR)

Part A: Safety Information

• Quantitative and Qualitative Composition:

  • Cannabidiol (CBD) – 500 mg per 40 ml
  • Olea Europaea (Olive) Fruit Oil
  • Helianthus Annuus (Sunflower) Seed Oil
  • Cera Alba (Beeswax) – Pharma Grade
  • Piper Nigrum (Black Pepper) Seed Extract
  • Capsaicin

• Physical/Chemical Characteristics and Stability:

  • Store at 15°C to 25°C, in a cool, dry place, away from direct sunlight.
  • Shelf Life: 3 years unopened; 12 months post-opening.

• Microbiological Quality: Meets standards for beeswax-based topical products.

• Impurities, Traces, and Packaging: Housed in EU-compliant transparent glass jars, with heavy metal checks performed as per DIN EN 13657:2003-01.

• Normal and Foreseeable Use: Apply to intact, healthy skin as directed.

Part B: Safety Assessment
Prepared by: Charalambos Georgiou, Chemical Engineer

The Hemp Hot Cream 500mg CBD with Piperine and Capsaicin has undergone a thorough safety evaluation and is produced under stringent quality guidelines. GMP-certified processes are employed for the CBD, capsaicin, and piperine used in the product. The Cera Alba (beeswax) utilized is registered with EOF and produced in a GMP-compliant facility.

Manufacturing Process and Quality Control
The CBD, piperine, and capsaicin are extracted and processed in facilities adhering to GMP standards. Capsaicin is manufactured under GMP conditions to ensure purity and quality. The final formulation is developed under controlled laboratory conditions, using closed-loop systems and sterilized equipment. Personnel wear safety uniforms, and access to the lab is restricted to maintain a contaminant-free environment. The lab undergoes rigorous daily cleaning with isopropyl and grain alcohol, and robotic vacuum cleaning is used to maintain cleanliness.

Storage Conditions
All finished products and raw materials are stored in a shared, climate-controlled area, free from humidity and sunlight, ensuring long-term stability and product quality.

5. Safety Profile and Precautions

CBD is generally well-tolerated, though some may experience mild effects like dry skin or irritation. Capsaicin, known for its warming sensation, may produce a tingling effect upon application. Avoid touching the eyes or mucous membranes after use, and wash hands thoroughly. This product is not recommended for use on broken skin or highly sensitive areas.

6. Conclusion

The Hemp Hot Cream 500mg CBD with Piperine and Capsaicin is formulated with safety and efficacy in mind, adhering to GMP processes and EU regulatory standards. The cream provides natural relief for discomfort and supports overall wellness through targeted topical application.

7. Labeling Information

• Label Includes:
  • Product name and CBD concentration
  • Full INCI ingredient list
  • CPNP registration number: 4629854
  • Usage instructions and recommended dosage
  • Manufacturer’s details and batch number
  • Net contents: 40 ml
  • Storage conditions and shelf life
  • No animal testing certification

8. References

• Atalay, S., Jarocka-Karpowicz, I., & Skrzydlewska, E. (2019). Antioxidative and anti-inflammatory properties of cannabidiol. Antioxidants, 9(1), 21. doi:10.3390/antiox9010021
• Baswan, S. M., Klosner, A. E., Glynn, K., Rajgopal, A., Malik, K., Yim, S., & Stern, N. (2020). Therapeutic potential of cannabidiol (CBD) for skin health and disorders. Clinical, Cosmetic and Investigational Dermatology, 13, 927-942. doi:10.2147/CCID.S274432
• Samanta, A., & Ghosh, M. (2012). Piperine: A bio-enhancer for improving the effectiveness of herbal treatments. Journal of Natural Remedies, 12(2), 104-111.
• Ghashghaie, H., Saadat, S., & Ghassemi, M. (2017). Anti-inflammatory effects of sunflower oil on human skin cells: A comprehensive review. Pharmacognosy Journal, 9(3), 404-410. doi:10.5530/pj.2017.3.66
• Morel, F., & Janis, K. (2017). Beeswax: Nature’s Emollient for Skin Care Applications. Journal of Cosmetic Science, 68(5), 433-441.
• Russo, E. B., & Hohmann, A. G. (2013). Role of cannabinoids in pain management. Journal of Therapeutic Pain Management, 4(4), 175-189. doi:10.2147/jtpm.s43244