Balsamum Peruvianum . Other Ingredients: Lactose, Sucrose.
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In 2004, Canada began regulating natural medicines as a category of products separate from foods or drugs. These products are officially recognized as "Natural Health Products." These products include vitamins, minerals, herbal preparations, homeopathic products, probiotics, fatty acids, amino acids, and other naturally derived supplements.
In order to be marketed in Canada, natural health products must be licensed. In order to be licensed in Canada, manufacturers must submit applications to Health Canada including information about uses, formulation, dosing, safety, and efficacy.
Products can be licensed based on several criteria. Some products are licensed based on historical or traditional uses. For example, if an herbal product has a history of traditional use, then that product may be acceptable for licensure. In this case, no reliable scientific evidence is required for approval.
For products with non-traditional uses, some level of scientific evidence may be required to support claimed uses. However, a high level of evidence is not necessarily required. Acceptable sources of evidence include at least one well-designed, randomized, controlled trial; well-designed, non-randomized trials; cohort and case control studies; or expert opinion reports.
Finished products licensed by Health Canada must be manufactured according to Good Manufacturing Practices (GMPs) as outlined by Health Canada.
This is a homeopathic preparation. Homeopathy is a system of medicine established in the 19th century by a German physician named Samuel Hahnemann. Its basic principles are that "like treats like" and "potentiation through dilution." For example, in homeopathy, diarrhea would be treated with an extreme dilution of a substance that normally causes diarrhea when taken in high doses.
Practitioners of homeopathy believe that more dilute preparations are more potent. Many homeopathic preparations are so diluted that they contain little or no active ingredient. Therefore, most homeopathic products are not expected to have any pharmacological effects, drug interactions, or other harmful effects. Any beneficial effects are controversial and cannot be explained by current scientific methods.
Dilutions of 1 to 10 are designated by an "X." So a 1X dilution = 1:10, 3X=1:1000; 6X=1:1,000,000. Dilutions of 1 to 100 are designated by a "C." So a 1C dilution = 1:100; 3C = 1:1,000,000. Dilutions of 24X or 12C or more contain zero molecules of the original active ingredient.
Homeopathic products are permitted for sale in the US due to legislation passed in 1938 sponsored by a homeopathic physician who was also a Senator. The law still requires that the FDA allow the sale of products listed in the Homeopathic Pharmacopeia of the United States. However, homeopathic preparations are not held to the same safety and effectiveness standards as conventional medicines. For more information, see the Homeopathy monograph.
Below is general information about the effectiveness of the known ingredients contained in the product Balsamum Peruvianum (Granule). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
There is insufficient reliable information available about the effectiveness of Peru balsam.
Below is general information about the safety of the known ingredients contained in the product Balsamum Peruvianum (Granule). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when Peru balsam is used in small amounts in food. Peru balsam has Generally Recognized as Safe (GRAS) status in the United States (4912).
POSSIBLY SAFE ...when Peru balsam preparations are used topically for less than 1 week, and in concentrations of 10% or less (2,19). In some individuals, Peru balsam is a contact allergen (11).
LIKELY UNSAFE ...when used orally in medicinal amounts; avoid using. Peru balsam is for external use only (2,6). Kidney damage can occur with internal consumption of large doses (18).
PREGNANCY: LIKELY UNSAFE
when used orally in medicinal amounts; avoid using (2,6,18).
There is insufficient reliable information available about the safety of Peru balsam when used topically; avoid using.
LACTATION: POSSIBLY UNSAFE
when used topically because systemic toxicity to babies can occur following application of Peru balsam to the nipples of nursing mothers (6).
LACTATION: LIKELY UNSAFE
when used orally in medicinal amounts; avoid using (2,6,18).
Below is general information about the interactions of the known ingredients contained in the product Balsamum Peruvianum (Granule). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Below is general information about the adverse effects of the known ingredients contained in the product Balsamum Peruvianum (Granule). Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General ...Peru balsam can cause kidney damage when taken orally or applied topically in large amounts (18). Topical use is associated with allergic contact dermatitis and other skin reactions (2,18).
Dermatologic
...There are numerous reports of Peru balsam and its extracts causing allergic contact dermatitis, particularly when present in fragrances, cosmetics, and topical medicines.
Among people who undergo patch testing for allergic contact dermatitis, reactions to Peru balsam occur in 4% to 8.4%, of whom 70% are women (100650,100908,100909). Peru balsam can also cause contact urticaria, phototoxic reactions, and non-immunological contact reactions (100909).
Two case reports describe cheilitis and perioral dermatitis associated with use of Lucas Papaw ointment (Lucas Papaw Remedies, Australia) containing Peru balsam, as a lip balm (100907).
Renal ...Use of Peru balsam orally or topically in large amounts can lead to kidney damage (18).