Chamomilla Recutita 6.0% w/w 1:10 standardized extract (DHE: 6 g) • Hamamelis virginiana 12.0% w/w. Other Ingredients: Aloe Vera Gel, Argan Oil, Beta Glucan, Butcher's Broom Extract, Cetearyl Olivate, Citric Acid, Grape Seed Oil, Grapefruit Seed Extract, Honeysuckle Flower Extract, Hydrogenated Olive Oil, Maltodextrin, Olive Oil, Olive Oil Unsaponifiables, Olive Squalene, Phospholipids, Seabuckthorn Berry Oil, Silica, Sorbitan Olivate, Sunflower Seed Oil, Vitamin A, Vitamin C, Vitamin E, Water, Xanthan Gum.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
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.
Below is general information about the effectiveness of the known ingredients contained in the product Thera Wise HmR Bio Active Hemorrhoidal Ointment. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Thera Wise HmR Bio Active Hemorrhoidal Ointment. 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 used orally in amounts commonly found in foods. German chamomile has Generally Recognized as Safe (GRAS) status in the US (4912,110318).
POSSIBLY SAFE ...when used orally, for medicinal purposes, short-term. German chamomile has been used with apparent safety at doses of up to 1500 mg daily for up to 26 weeks (6655,12724,12729,13089,19377,19716,104806,111380). ...when applied topically. A lotion containing 0.2% microencapsulated German chamomile extract has been applied to the skin with apparent safety for up to 35 days (108993). ...when used topically as an oral rinse (99853).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term.
Preliminary clinical research suggests that several multi-ingredient products containing German chamomile are safe in infants when used for up to 4 weeks (16735,19705,19715,96278). ...when used topically and appropriately, short-term. Six drops of oil infused with German chamomile flower has been applied nightly with apparent safety for up to 6 weeks in children 6-18 years old (98621).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when witch hazel water is used topically and appropriately (272).
POSSIBLY SAFE ...when used orally and appropriately (12). In high doses, tannins in witch hazel bark can cause liver damage (8). The volatile oil contains safrole, a known carcinogen, but in amounts too small for concern (4).
CHILDREN: POSSIBLY SAFE
when applied topically and appropriately (67795).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Thera Wise HmR Bio Active Hemorrhoidal Ointment. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, German chamomile might have additive effects when used with CNS depressants.
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Theoretically, large amounts of German chamomile might reduce the effectiveness of oral contraceptives.
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In vitro, German chamomile has demonstrated antiestrogenic activity (12728). Theoretically, concomitant use of large amounts of German chamomile might interfere with contraceptive drugs through competition for estrogen receptors.
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Theoretically, German chamomile might inhibit CYP1A2 and increase levels of drugs metabolized by these enzymes.
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Theoretically, German chamomile might inhibit CYP2C9 and increase levels of drugs metabolized by these enzymes.
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In vitro evidence shows that German chamomile might inhibit CYP2C9 (19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP2C9 in patients taking German chamomile.
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Theoretically, German chamomile might inhibit CYP2D6 and increase levels of drugs metabolized by these enzymes.
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In vitro evidence shows that German chamomile might inhibit CYP2D6 (19720). So far, this interaction has not been reported in humans. However, there might be an increase in the levels of drugs metabolized by CYP2D6 in patients taking German chamomile.
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Theoretically, German chamomile might inhibit CYP3A4 and increase levels of drugs metabolized by these enzymes.
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Theoretically, large amounts of German chamomile might reduce the effectiveness of estrogens.
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In vitro, German chamomile has demonstrated antiestrogenic activity (12728). Theoretically, large amounts of German chamomile might interfere with hormone replacement therapy through competition for estrogen receptors.
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Theoretically, large amounts of German chamomile might interfere with the activity of tamoxifen.
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In vitro, German chamomile has demonstrated antiestrogenic activity (12728).
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German chamomile might increase the effects of warfarin and increase the risk of bleeding.
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In one case, a 70-year-old female taking warfarin developed retroperitoneal hematoma and bilateral recti muscle bleeding along with an INR of 7.9 following ingestion of German chamomile tea 4-5 cups daily and use of a topical chamomile-based lotion applied 4-5 times daily (14309).
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Below is general information about the adverse effects of the known ingredients contained in the product Thera Wise HmR Bio Active Hemorrhoidal Ointment. 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
...Orally and topically, German chamomile is well tolerated.
Most Common Adverse Effects:
Orally and topically: Allergic reactions and irritation.
Dermatologic ...Topically, German chamomile may cause allergic dermatitis and eczema (9766,9768,10377,110318).
Gastrointestinal ...When used topically as an oral rinse, German chamomile has been reported to cause nausea and burning in the mouth in some patients (99853).
Immunologic ...Orally, German chamomile tea can cause allergic reactions including severe hypersensitivity reactions and anaphylaxis in some patients (567). In one case report, a 47-year-old female who tolerated drinking chamomile tea, reported sneezing, nasal and ocular itching, red and watery eyes, and severe rhinorrhea after 10 years of occupational exposure to German chamomile dust (90542).
Ocular/Otic ...If used near the eyes, German chamomile can cause irritation (10377).
General
...Witch hazel contains tannins.
The leaf contains 8% to 10% tannins, while the bark contains up to 12% (512,10377,93894).Orally, plants with at least 10% tannins can cause gastrointestinal disturbances, kidney damage, and necrotic conditions of the liver (12). Some evidence suggests that tannins might cause cancer; other evidence shows tannins may prevent it (12). Regular consumption of herbs with high tannin concentrations correlates with increased incidence of esophageal or nasal cancer (12).
Topically, witch hazel can cause contact dermatitis, redness, and burning (6,67795,86505).
Dermatologic ...Topically, witch hazel can cause contact dermatitis (6,86505). A small number of people develop redness or burning (67795).
Gastrointestinal ...Witch hazel contains tannins, with the leaf containing 8% to 10% tannins and the bark containing up to 12% tannins (512,10377,93894). Orally, plants with at least 10% tannins can cause gastrointestinal disturbances (12).
Hepatic ...Witch hazel contains tannins, with the leaf containing 8% to 10% tannins and the bark containing up to 12% tannins (512,10377,93894). Orally, plants with at least 10% tannins can cause necrotic conditions of the liver (12).
Oncologic ...Witch hazel contains tannins, with the leaf containing 8% to 10% tannins and the bark containing up to 12% tannins (512,10377,93894). Some evidence suggests that tannins might cause cancer; other evidence shows tannins may prevent it (12). Regular consumption of herbs with high tannin concentrations correlates with increased incidence of esophageal or nasal cancer (12).
Renal ...Witch hazel contains tannins, with the leaf containing 8% to 10% tannins and the bark containing up to 12% tannins (512,10377,93894). Orally, plants with at least 10% tannins can cause kidney damage (12).
