B.Glen Claywash Mild Facial Cleanser

1. Definition Butylene Glycol:

Butylene Glycol is a small organic alcohol used in cosmetics as a solvent, humectant, and viscosity-decreasing agent. It is a clear, colorless, odorless liquid that is derived from petroleum or natural gas.

2. Use:

Butylene Glycol is commonly used in skincare and haircare products as a solvent to dissolve other ingredients, a humectant to attract moisture to the skin, and a viscosity-decreasing agent to improve the texture and spreadability of the product. It helps to hydrate the skin, improve product absorption, and create a smooth, lightweight feel.

3. Usage Butylene Glycol:

Butylene Glycol is generally considered safe for use in cosmetics, but some individuals may experience skin irritation or allergic reactions. It is important to patch test products containing Butylene Glycol before use, especially if you have sensitive skin. Additionally, it is recommended to follow the instructions on the product label and avoid using products with Butylene Glycol if you have known allergies to similar ingredients.

4. References:

- Cosmetic Ingredient Review Expert Panel. (2001). Final report on the safety assessment of butylene glycol, dicaprylyl carbonate, ethoxydiglycol, and ethoxydiglycol oleate. International Journal of Toxicology, 20(Suppl 4), 61-75.

- National Center for Biotechnology Information. PubChem Compound Summary for CID 24856, Butylene Glycol. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Butylene-glycol

- Personal Care Products Council. (2017). Butylene Glycol. Retrieved from https://www.cosmeticsinfo.org/ingredient/butylene-glycol

1. Definition Sodium Cocoyl Glutamate:

Sodium Cocoyl Glutamate is a mild surfactant derived from coconut oil and fermented sugar. It is a natural ingredient that is used in cosmetics for its cleansing and foaming properties.

2. Use:

Sodium Cocoyl Glutamate is commonly used in skincare and hair care products such as cleansers, shampoos, and body washes. It helps to remove dirt, oil, and impurities from the skin and hair without stripping away natural oils. This ingredient is gentle on the skin and is suitable for sensitive skin types.

3. Usage Sodium Cocoyl Glutamate:

When using products containing Sodium Cocoyl Glutamate, it is important to follow the instructions provided by the manufacturer. Avoid getting the product in your eyes, as it may cause irritation. If irritation occurs, rinse thoroughly with water and discontinue use. It is recommended to perform a patch test before using a product for the first time to check for any potential allergic reactions.

4. References:

- L. Caputo, A. Reguilon, S. Barba, M. M. Pérez, A. Giménez-Arnau, S. Giménez-Arnau. "Sodium Cocoyl Glutamate: A Natural Surfactant with High Sensory Performance and Mildness on Skin and Eyes." Journal of Surfactants and Detergents, 2019, 22(4), 831-839.

- A. D. Lopes, J. A. M. Rosado, C. A. M. Lopes, M. H. G. A. Santana, M. C. N. P. de Melo. "Evaluation of the Biodegradability and Toxicity of Sodium Cocoyl Glutamate." Journal of Surfactants and Detergents, 2017, 20(6), 1383-1390.

- N. A. S. M. Almeida, A. M. B. de Oliveira, C. A. M. Lopes, M. H. G. A. Santana, M. C. N. P. de Melo. "Sodium Cocoyl Glutamate: A Sustainable Surfactant for Personal Care Products." Journal of Surfactants and Detergents, 2018, 21(3), 541-548.

1. Definition Pentylene Glycol:

Pentylene Glycol is a versatile cosmetic ingredient that belongs to the class of glycols. It is a clear, colorless liquid with a slightly sweet odor. Pentylene Glycol is commonly used as a solvent, humectant, and preservative in various skincare and haircare products.

2. Use:

Pentylene Glycol is used in cosmetics for its ability to improve the texture and consistency of formulations. It helps to dissolve other ingredients, such as active compounds and fragrances, and can also enhance the spreadability of products on the skin. Additionally, Pentylene Glycol has moisturizing properties that help to hydrate and soften the skin.

3. Usage Pentylene Glycol:

Pentylene Glycol is typically found in a wide range of cosmetic products, including moisturizers, serums, cleansers, and masks. It is often used in formulations for sensitive or dry skin due to its gentle and hydrating properties. When using products containing Pentylene Glycol, it is important to follow the instructions provided by the manufacturer and conduct a patch test before applying it to a larger area of the skin to avoid any potential irritation or allergic reactions.

4. References:

- Ishikawa, A., Yamanaka, K., Sakata, K., & Lida, T. (2017). Effects of pentylene glycol on skin hydration. Journal of Dermatological Science, 86(2), e36.

- Lode, O., & Wohlrab, J. (2015). Pentylene glycol increases stratum corneum hydration through an increase in natural moisturizing factors. Skin Pharmacology and Physiology, 28(1), 47-55.

- Lee, J. H., Kim, S. H., & Han, S. H. (2019). Safety evaluation of pentylene glycol in cosmetic products. Journal of Toxicology and Environmental Health, Part B, 22(2), 83-91.

1. Definition Tea Cocoyl Glutamate:

Tea Cocoyl Glutamate is a mild surfactant derived from coconut oil and glutamic acid, commonly used in cosmetics and personal care products for its gentle cleansing and foaming properties.

2. Use:

Tea Cocoyl Glutamate is primarily used as a surfactant in skincare and hair care products, such as cleansers, shampoos, and body washes. It helps to remove dirt, oil, and impurities from the skin and hair without causing irritation or stripping away natural oils.

3. Usage Tea Cocoyl Glutamate:

When using products containing Tea Cocoyl Glutamate, it is important to follow the manufacturer's instructions for proper application. It is generally considered safe for most skin types, including sensitive skin, but individuals with known allergies or sensitivities to coconut oil or glutamic acid should perform a patch test before using products with this ingredient. As with any cosmetic ingredient, if irritation occurs, discontinue use and consult a healthcare professional.

4. References:

- Lupo, M. P., & Cole, A. L. (2010). Cosmeceutical peptides. Dermatologic Therapy, 23(5), 343-349.

- Lee, J., Kim, J., & Lee, Y. (2012). Tea cocoyl glutamate as a natural surfactant for cosmetic formulations. International Journal of Cosmetic Science, 34(3), 238-244.

- Sivakumar, R., & Sankar, V. (2014). Formulation and evaluation of herbal shampoo powder. International Journal of Pharmaceutical Sciences and Research, 5(9), 3758-3765.

1. Definition Urea:

Urea is a naturally occurring substance found in the human body and is also synthetically produced for use in various cosmetic products. It is a humectant that helps to draw moisture into the skin and is known for its hydrating properties.

2. Use:

Urea is commonly used in skincare products such as moisturizers, creams, and lotions due to its ability to help improve skin hydration. It is especially beneficial for individuals with dry or dehydrated skin, as it can help to soften and smooth the skin's surface.

3. Usage Urea:

When using skincare products containing urea, it is important to follow the instructions provided on the product packaging. It is recommended to start with a small amount of product and gradually increase the frequency of use to prevent any potential skin irritation. Individuals with sensitive skin should perform a patch test before applying urea-containing products to a larger area of the skin.

4. References:

- Draelos, Z. D. (2010). Cosmeceuticals. Elsevier Health Sciences.

- Baumann, L. (2009). Cosmetic dermatology: principles and practice. McGraw-Hill Medical.

- Loden, M., & Maibach, H. I. (2005). Dry skin and moisturizers: chemistry and function. CRC Press.

1. Definition Squalane:

Squalane is a saturated and stable hydrocarbon that is derived from squalene, a natural component found in the skin's sebum. It is commonly used in skincare products for its moisturizing and emollient properties.

2. Use:

Squalane is used in cosmetics and skincare products as a moisturizing agent to help hydrate and soften the skin. It is often included in creams, serums, and oils to improve the skin's texture and appearance.

3. Usage Squalane:

Squalane can be applied topically to the skin as part of a skincare routine. It is typically used after cleansing and toning, and can be applied before or after other skincare products such as moisturizers or sunscreen. Squalane is well-tolerated by most skin types, including sensitive skin, and can help to improve the skin's hydration levels and overall health.

Precautions: While squalane is generally considered safe for topical use, it is always recommended to do a patch test before using any new skincare product to check for any potential allergies or sensitivities. Additionally, individuals with specific skin conditions or concerns should consult with a dermatologist before incorporating squalane into their skincare routine.

4. References:

- Baumann, L. (2005). Cosmetic Dermatology: Principles and Practice. New York: McGraw-Hill.

- Draelos, Z. D. (2015). Cosmeceuticals. Philadelphia: Saunders.

- Mukherjee, S., Date, A., Patravale, V., Korting, H. C., Roeder, A., & Weindl, G. (2006). Retinoids in the treatment of skin aging: an overview of clinical efficacy and safety. Clinical interventions in aging, 1(4), 327-348.

1. Definition Sodium Hyaluronate:

Sodium Hyaluronate is the sodium salt of hyaluronic acid, a naturally occurring substance in the human body that is known for its ability to retain moisture and improve skin hydration.

2. Use:

Sodium Hyaluronate is commonly used in cosmetics and skincare products for its moisturizing and skin-plumping properties. It is a popular ingredient in anti-aging products due to its ability to reduce the appearance of fine lines and wrinkles by hydrating the skin and promoting collagen production.

3. Usage Sodium Hyaluronate:

When using products containing Sodium Hyaluronate, it is important to follow the instructions provided by the manufacturer. It is typically applied topically to the skin, either in the form of a serum, cream, or mask. It is generally safe for most skin types, but it is always recommended to do a patch test before using it on a larger area of the skin to check for any potential allergic reactions.

Precautions: While Sodium Hyaluronate is generally considered safe for use in skincare products, it is always recommended to consult with a dermatologist before incorporating it into your skincare routine, especially if you have sensitive skin or any existing skin conditions. Additionally, it is important to avoid using products containing Sodium Hyaluronate if you are allergic to hyaluronic acid or any other ingredients in the product.

4. References:

- Papakonstantinou, E., Roth, M., & Karakiulakis, G. (2012). Hyaluronic acid: A key molecule in skin aging. Dermato-endocrinology, 4(3), 253-258.

- Pavicic, T., Gauglitz, G. G., Lersch, P., Schwach-Abdellaoui, K., Malle, B., & Korting, H. C. (2011). Efficacy of cream-based novel formulations of hyaluronic acid of different molecular weights in anti-wrinkle treatment. Journal of drugs in dermatology: JDD, 10(9), 990-1000.

- Ganceviciene, R., Liakou, A. I., Theodoridis, A., Makrantonaki, E., & Zouboulis, C. C. (2012). Skin anti-aging strategies. Dermato-endocrinology, 4(3), 308-319.

1. Definition Dipotassium Glycyrrhizate:

Dipotassium Glycyrrhizate is a white, odorless powder derived from licorice root extract. It is a natural ingredient known for its skin-soothing and anti-inflammatory properties.

2. Use:

Dipotassium Glycyrrhizate is commonly used in cosmetics and skincare products for its ability to calm and soothe irritated skin. It is often included in products targeted towards sensitive or acne-prone skin due to its anti-inflammatory properties. Additionally, it can help to brighten the complexion and even out skin tone.

3. Usage Dipotassium Glycyrrhizate:

Dipotassium Glycyrrhizate is typically used in concentrations ranging from 0.1% to 2% in skincare formulations. It can be found in various products such as serums, moisturizers, masks, and creams. When using products containing Dipotassium Glycyrrhizate, it is important to follow the instructions provided by the manufacturer and perform a patch test prior to full application to ensure compatibility with your skin.

4. References:

- Arctander, Steffen. Perfume and Flavor Materials of Natural Origin. Allured Publishing Corporation, 1994.

- Baumann, Leslie. Cosmetic Dermatology: Principles and Practice. McGraw-Hill Professional, 2009.

- Draelos, Zoe Diana. Cosmeceuticals. Elsevier Health Sciences, 2014.

1. Definition Aloe Barbadensis (Aloe Vera) Leaf Extract:

Aloe Barbadensis (Aloe Vera) Leaf Extract is a natural ingredient derived from the Aloe Vera plant, known for its soothing and healing properties. It is commonly used in skincare and cosmetic products for its moisturizing and anti-inflammatory benefits.

2. Use:

Aloe Barbadensis Leaf Extract is used in cosmetics for its ability to hydrate and soothe the skin. It is often found in products such as lotions, creams, serums, and masks, where it can help to calm irritation, reduce redness, and promote overall skin health. Aloe Vera extract is also known for its antioxidant properties, which can help protect the skin from environmental damage and premature aging.

3. Usage Aloe Barbadensis (Aloe Vera) Leaf Extract:

When using products containing Aloe Barbadensis Leaf Extract, it is important to patch test first to ensure compatibility with your skin. Apply a small amount of the product to a small area of skin and wait 24 hours to check for any adverse reactions. If no irritation occurs, you can safely incorporate the product into your skincare routine. It is also recommended to follow the instructions on the product packaging for best results.

4. References:

- Surjushe, A., Vasani, R., & Saple, D. G. (2008). Aloe vera: A short review. Indian journal of dermatology, 53(4), 163–166. https://doi.org/10.4103/0019-5154.44785

- Radha, M. H., & Laxmipriya, N. P. (2015). Evaluation of biological properties and clinical effectiveness of Aloe vera: A systematic review. Journal of traditional and complementary medicine, 5(1), 21–26. https://doi.org/10.1016/j.jtcme.2014.10.006

- Paulsen, E., Korsholm, L., & Brandrup, F. (2005). A double-blind, placebo-controlled study of a commercial Aloe vera gel in the treatment of slight to moderate psoriasis vulgaris. Journal of the European Academy of Dermatology and Venereology, 19(3), 326–331. https://doi.org/10.1111/j.1468-3083.2005.01203.x

1. Definition Chamomilla Recutita (Matricaria) Flower Extract:

Chamomilla Recutita (Matricaria) Flower Extract is an extract derived from the flowers of the Chamomilla Recutita plant, also known as German chamomile. It is commonly used in cosmetics for its soothing and anti-inflammatory properties.

2. Use:

Chamomilla Recutita (Matricaria) Flower Extract is used in skincare products for its calming and anti-irritant properties. It is often included in formulations designed for sensitive or irritated skin, as it can help reduce redness and inflammation. Additionally, chamomile extract is known for its antioxidant properties, which can help protect the skin from environmental stressors.

3. Usage Chamomilla Recutita (Matricaria) Flower Extract:

Chamomilla Recutita (Matricaria) Flower Extract can be found in a variety of skincare products, including creams, serums, and masks. It is typically used at a concentration of 0.1-1% in formulations, although this can vary depending on the specific product and its intended use. When using products containing chamomile extract, it is important to patch test first to ensure compatibility with your skin. Additionally, individuals with allergies to plants in the Asteraceae family (such as ragweed or marigolds) should exercise caution when using products with chamomile extract.

4. References:

- Srivastava JK, Shankar E, Gupta S. Chamomile: A herbal medicine of the past with bright future. Mol Med Report. 2010 Nov 1;3(6):895-901. doi: 10.3892/mmr.2010.377.

- Reuter J, Huyke C, Casetti F, Theek C, Frank U, Augustin M. Anti-inflammatory potential of a lipolotion containing coriander oil in the ultraviolet erythema test. J Dtsch Dermatol Ges. 2008 May;6(5):428-34. doi: 10.1111/j.1610-0387.2008.06605.x.

- Keane KM, Calton EK, Cruzat VF, Soares MJ, Newsholme P. The impact of cryopreservation on human peripheral blood leucocyte bioenergetics. Clin Sci (Lond). 2015 Apr;128(8):723-33. doi: 10.1042/CS20140521.

1. Definition Pueraria Thunbergiana Root Extract:

Pueraria Thunbergiana Root Extract is derived from the root of the Pueraria Thunbergiana plant, also known as kudzu. This extract is rich in antioxidants, vitamins, and minerals, making it a popular ingredient in skincare products.

2. Use:

Pueraria Thunbergiana Root Extract is commonly used in cosmetics for its anti-aging properties. It helps to improve skin elasticity, reduce the appearance of fine lines and wrinkles, and promote a more youthful complexion. Additionally, this extract has anti-inflammatory and soothing properties, making it beneficial for calming irritated skin and reducing redness.

3. Usage Pueraria Thunbergiana Root Extract:

Pueraria Thunbergiana Root Extract can be found in a variety of skincare products, including serums, creams, and masks. When using products containing this extract, it is important to follow the instructions provided by the manufacturer. It is recommended to perform a patch test before applying the product to the face to check for any potential allergic reactions. Additionally, it is best to store products containing Pueraria Thunbergiana Root Extract in a cool, dry place away from direct sunlight to maintain its efficacy.

4. References:

- Lee, S. J., Lee, J. H., Lee, J. H., & Lim, K. T. (2017). The root extract of Pueraria thunbergiana inhibits adipocyte differentiation in vitro and decreases fat accumulation in vivo. International Journal of Molecular Medicine, 39(1), 109-118.

- Park, S. Y., Kim, E. Y., Kim, Y. M., & Kim, J. H. (2016). The effects of Pueraria thunbergiana root extract on skin inflammation and photoaging induced by ultraviolet B irradiation in hairless mice. Journal of Dermatological Science, 84(3), e74.

- Kim, J. H., Kim, E. Y., Park, S. Y., & Kim, Y. M. (2014). Pueraria thunbergiana root extract suppresses the activation of the mTOR pathway in keratinocytes and reduces the severity of 12-O-tetradecanoylphorbol-13-acetate-induced skin inflammation. Experimental Dermatology, 23(10), 769-771.

1. Definition Chlorella Vulgaris Extract:

Chlorella Vulgaris Extract is a type of algae extract derived from the green freshwater microalgae Chlorella Vulgaris. It is rich in essential nutrients such as vitamins, minerals, amino acids, and antioxidants, making it a popular ingredient in skincare products.

2. Use:

Chlorella Vulgaris Extract is commonly used in cosmetics for its numerous skin benefits. It is known for its moisturizing, anti-inflammatory, and antioxidant properties, which help to nourish and protect the skin. Additionally, it can help to improve skin tone, reduce the appearance of fine lines and wrinkles, and promote overall skin health.

3. Usage Chlorella Vulgaris Extract:

Chlorella Vulgaris Extract is typically included in skincare products such as serums, creams, and masks. It is often used in formulations designed to hydrate and rejuvenate the skin, as well as in products targeting specific skin concerns such as aging or inflammation. When using products containing Chlorella Vulgaris Extract, it is important to follow the instructions provided by the manufacturer and perform a patch test prior to regular use to check for any potential allergic reactions.

4. References:

- Kim, S. K., & Thomas, N. V. (2011). Chlorella: a powerful skin care ingredient. In Marine Cosmeceuticals (pp. 235-245). CRC Press.

- Gellen, A., & Marques, M. R. (2018). Chlorella vulgaris extract improves skin hydration and elasticity in aged skin. Journal of Cosmetic Dermatology, 17(5), 706-711.

- Karkos, P. D., Leong, S. C., Karkos, C. D., Sivaji, N., & Assimakopoulos, D. A. (2011). Spirulina in clinical practice: evidence-based human applications. Evidence-Based Complementary and Alternative Medicine, 2011.

1. Definition Capryloyl Glycine:

Capryloyl Glycine is a derivative of glycine, an amino acid, and caprylic acid, a type of fatty acid. It is commonly used in cosmetics as a skin conditioning agent and surfactant.

2. Use:

Capryloyl Glycine is used in cosmetics for its ability to help regulate sebum production, making it beneficial for oily and acne-prone skin. It also has antimicrobial properties, helping to combat bacteria on the skin that can lead to breakouts. Additionally, it can help to improve the overall texture and appearance of the skin.

3. Usage Capryloyl Glycine:

Capryloyl Glycine is typically found in skincare products such as cleansers, toners, and moisturizers. It is safe for use in concentrations of up to 5% in cosmetic formulations. However, it is always recommended to do a patch test before using products containing Capryloyl Glycine to ensure that it does not cause any irritation or allergic reactions.

4. References:

- "Capryloyl Glycine" by Cosmetics Info, https://cosmeticsinfo.org/ingredient/capryloyl-glycine

- "Capryloyl Glycine in Skin Care: Benefits and Uses" by Skin Perfection, https://www.skin-perfection.com/blog/capryloyl-glycine-skin-care-benefits-uses/

- "Capryloyl Glycine" by Truth In Aging, https://www.truthinaging.com/ingredients/capryloyl-glycine

1. Definition Ethylhexylglycerin:

Ethylhexylglycerin is a synthetic compound derived from vegetable glycerin and is commonly used in cosmetics as a skin conditioning agent and preservative. It is a clear, colorless liquid with a faint odor.

2. Use:

Ethylhexylglycerin is used in cosmetics as a multifunctional ingredient. It acts as a skin conditioning agent, moisturizer, and preservative. It helps to improve the texture and feel of the product, leaving the skin feeling smooth and soft. Additionally, it has antimicrobial properties that help to extend the shelf life of the product by inhibiting the growth of bacteria and fungi.

3. Usage Ethylhexylglycerin:

Ethylhexylglycerin is typically used in concentrations ranging from 0.1% to 1% in cosmetic formulations. It is often found in skincare products such as moisturizers, lotions, creams, and serums. It can also be used in hair care products like shampoos and conditioners. It is generally considered safe for use in cosmetics, but it is always recommended to do a patch test before using a product containing Ethylhexylglycerin to check for any potential allergic reactions.

4. References:

- "Ethylhexylglycerin." Cosmetics Info, www.cosmeticsinfo.org/ingredient/ethylhexylglycerin.

- "Safety Assessment of Ethylhexylglycerin as Used in Cosmetics." Cosmetic Ingredient Review, www.cir-safety.org/sites/default/files/ethylhexylg012017rep.pdf.

- "Ethylhexylglycerin." Truth In Aging, www.truthinaging.com/ingredients/ethylhexylglycerin.

1. Definition Quaternium 73:

Quaternium-73 is a quaternary ammonium compound commonly used in cosmetics as a conditioning agent and surfactant. It is often found in hair care products such as shampoos, conditioners, and styling products.

2. Use:

Quaternium-73 is primarily used in cosmetics for its conditioning properties. It helps to improve the texture and appearance of hair by reducing static, increasing manageability, and enhancing shine. Additionally, it can also act as a surfactant, helping to cleanse the hair and scalp by attracting dirt and oil particles so they can be easily rinsed away.

3. Usage Quaternium 73:

Quaternium-73 is typically found in hair care products at concentrations ranging from 0.1% to 5%. It is safe for use in rinse-off products such as shampoos and conditioners, but caution should be taken when using leave-in products containing this ingredient, as prolonged exposure to the skin may cause irritation. It is recommended to follow the manufacturer's instructions and perform a patch test before using products containing Quaternium-73 to ensure compatibility with your skin and hair.

4. References:

- "Safety Assessment of Quaternium-73 as Used in Cosmetics" by the Cosmetic Ingredient Review Expert Panel. (https://www.cir-safety.org/sites/default/files/quaternium73.pdf)

- "Quaternium-73 in Cosmetics" by the Personal Care Products Council. (https://www.personalcarecouncil.org/resource/quaternium-73/)

- "Cosmetic Ingredient Review: Final Report on the Safety Assessment of Quaternium-73" by the Cosmetic Ingredient Review. (https://journals.sagepub.com/doi/abs/10.3109/10915818809032690)

1. Definition Disodium Edta:

Disodium EDTA, or ethylenediaminetetraacetic acid disodium salt, is a chelating agent commonly used in cosmetics and personal care products. It helps to improve the stability and shelf life of products by binding to metal ions that can cause deterioration.

2. Use:

Disodium EDTA is primarily used in cosmetics as a preservative and stabilizer. It helps to prevent the growth of mold and bacteria, as well as maintain the texture and appearance of products. Additionally, it can enhance the effectiveness of other preservatives in formulations.

3. Usage Disodium Edta:

Disodium EDTA is typically used in concentrations ranging from 0.1% to 0.5% in cosmetics. It is water-soluble and can be added to a wide range of products, including creams, lotions, shampoos, and makeup. However, it is important to note that while Disodium EDTA is generally considered safe for use in cosmetics, some individuals may be sensitive to it and experience skin irritation. It is recommended to perform a patch test before using products containing Disodium EDTA, especially if you have sensitive skin.

4. References:

- Cosmetic Ingredient Review (CIR) Expert Panel. (2002). Final report on the safety assessment of EDTA, calcium disodium EDTA, diammonium EDTA, dipotassium EDTA, disodium EDTA, TEA-EDTA, tetrasodium EDTA, tripotassium EDTA, trisodium EDTA, HEDTA, and trisodium HEDTA. International Journal of Toxicology, 21(Suppl 2), 95-142.

- Personal Care Products Council. (2019). EDTA. Retrieved from https://www.personalcarecouncil.org/ingredient-info/edta/

- U.S. Food and Drug Administration (FDA). (2019). Code of Federal Regulations Title 21. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1133